Sanofi delivers strong 2019 business EPS growth of 6.8% at CER
Sanofi delivers strong 2019
business EPS growth of 6.8% at CER
|
Q4 2019 |
Change |
Change at CER |
2019 |
Change |
Change at CER |
IFRS net sales reported |
€9,608m |
+6.8% |
+4.7% |
€36,126m |
+4.8% |
+2.8% |
IFRS net income reported |
-€10m |
-103.9%(2) |
- |
€2,806m |
-34.8%(2) |
- |
IFRS EPS
reported |
-€0.01 |
-105.0%(2) |
- |
€2.24 |
-35.1%(2) |
- |
Business net income(1) |
€1,684m |
+23.5% |
+18.4% |
€7,489m |
+9.8% |
+7.0% |
Business
EPS(1 |
€1.34 |
+21.8% |
+17.3% |
€5.99 |
+9.5% |
+6.8% |
Fourth-quarter 2019 sales performance(3) driven by
Dupixent® and Vaccines
- Net sales were €9,608 million, up 6.8% on a reported basis and
4.7%(3) at CER.
- Dupixent® (global sales €679 million, up 135%) the largest
growth contributor, drove Sanofi Genzyme GBU sales up 19.7%.
- Vaccines sales increased 22.0%, reflecting majority of U.S.
influenza vaccine shipments in Q4.
- CHC sales down 5.2%, mainly due to Zantac® voluntary recall,
non-core divestments and changing regulatory requirements.
- Primary Care GBU sales declined 8.7% due to lower sales in
Diabetes and Established Products.
- Lower China sales (down 21.0%) due to anticipated price and
inventory adjustments on Plavix® and Avapro® in the channel.
Full-year 2019 sales growth of 3.6% at CER/CS(4) and
business EPS growth of 6.8% at CER
- Net sales were €36,126 million, up 4.8% on a reported basis and
2.8% at CER (up 3.6% at CER/CS(4)).
- Dupixent® sales reached €2,074 million, on track with ambition
to achieve more than €10 billion peak sales.
- Vaccines sales increased 9.3% to €5,731 million, supporting
expected mid-to-high single digit CAGR from 2018 to 2025.
- Business operating income margin improved 1.2 percentage points
to 27.0%, trending towards objective of 30% by 2022.
- Q4 2019 business EPS(1) up 17.3% at CER to €1.34.
- Full-year 2019 business EPS of €5.99 up 6.8% at CER.
- Full-year 2019 IFRS EPS of €2.24 (down 35.1%(2)), reflecting a
€3.6 billion impairment charge mainly related to Eloctate®.
- Board proposes annual dividend of €3.15, the 26th consecutive
increase in dividend.
Significant R&D advances and regulatory
milestones
- SAR442168, a BTK inhibitor, achieved proof of concept in
relapsing multiple sclerosis; phase 3 program to be initiated
mid-2020.
- Dupixent® submitted to FDA (priority review) and EMA as first
biologic for children aged 6-11 years with atopic dermatitis.
- Dupixent® phase 3 pivotal studies initiated in bullous
pemphigoid, chronic spontaneous urticaria and prurigo
nodularis.
- Dupixent® efficacy and safety further supported by 3-year data
from OLE (Open Label Extension) study.
- Fluzone® High-Dose Quadrivalent approved in the U.S.
- Sutimlimab demonstrated positive phase 3 results in cold
agglutinin disease.
- SAR408701, an anti-CEACAM5 antibody-drug conjugate, entered
into phase 3 in non-small cell lung cancer.
- Olipudase demonstrated positive pivotal topline data in adult
and pediatric patients with acid sphingomyelinase deficiency.
- Successful completion of Synthorx acquisition enhances Sanofi’s
position as an emerging leader in oncology and immunology.
2020 financial outlook Sanofi expects 2020
business EPS(1) to grow around 5%(5) at CER, barring unforeseen
major adverse events. Applying average January 2020 exchange rates,
the positive currency impact on 2020 business EPS is estimated to
be around 1%. |
Sanofi Chief Executive Officer,
Paul Hudson, commented: “I am encouraged by the fourth
quarter results which position Sanofi to deliver on our new
strategic priorities. The acceleration in sales performance was
mainly driven by the impressive growth of Dupixent®, our
transformative medicine for type 2 inflammatory diseases and by our
differentiated Vaccines portfolio. At the same time, our sharpened
focus on operating and financial efficiencies helped us to deliver
margin expansion and significant cash flow improvement. We are
making great progress in our ambition to transform Sanofi R&D
and I am particularly excited by the positive proof of concept data
for our BTK inhibitor, a potentially practice changing therapy for
multiple sclerosis, announced today. There is increasing momentum
across the entire Sanofi organization and I am confident we will
achieve the long-term growth aspirations and margin targets we set
out at our Capital Markets Day”. |
(1) In order to facilitate an
understanding of operational performance, Sanofi comments on the
business net income statement. Business net income is a non-GAAP
financial measure (see Appendix 11 for definitions). The
consolidated income statement for Q4 2019 is provided in Appendix 3
and a reconciliation of reported IFRS net income to business net
income is set forth in Appendix 4; (2) Q4 2019 and full-year 2019
included impairment charge of €1,581 million and €3,604 million,
respectively, mainly related to Eloctate®; (3) Changes in net sales
are expressed at constant exchange rates (CER) unless otherwise
indicated (see Appendix 11); (4) Constant Structure: Adjusted for
divestment of European generics business and sales of Bioverativ
products to SOBI; (5) Base for business EPS growth is €5.97,
reflecting 2 cents impact from IFRS 16 (see appendix
11).
Investor Relations: (+) 33 1 53 77 45 45 -
E-mail: IR@sanofi.com - Media
Relations: (+) 33 1 53 77 46 46 - E-mail:
MR@sanofi.comWebsite: www.sanofi.com |
2019 fourth-quarter and
full-year Sanofi sales
Unless otherwise indicated, all
percentage changes in sales in this press release are stated at
CER(6). |
In the fourth quarter of 2019, Company
sales were €9,608 million, up 6.8% on a reported basis. Exchange
rate movements had a positive effect of 2.1 percentage points,
mainly driven by the strength of the U.S. dollar and the Japanese
yen. At CER, Company sales increased 4.7%. Full-year 2019 Company
sales reached €36,126 million, up 4.8% on a reported basis.
Exchange rate movements had a favorable effect of 2.0 percentage
points. At CER, Company sales were up 2.8%.
Global Business
Units
At its Capital Markets Day in December
2019, Sanofi announced plans for a new GBU organization(7) which
will include three core GBUs, Specialty Care, General Medicines and
Vaccines together with a standalone Consumer Healthcare business.
The General Medicines GBU will be created from two existing GBUs,
Primary Care and China & Emerging Markets. Each GBU will
include its respective Emerging Markets sales
contribution.Olivier Charmeil has been appointed
to lead the General Medicines GBU. Olivier is one of Sanofi’s most
seasoned business leaders. He will draw on his recent experience
leading the China & Emerging Markets GBU to engage with
customers and markets and ensure that our combined Diabetes,
Cardiovascular and Established Products business drives growth and
deliver for patients around the world.Alongside
the GBU reorganization, Sanofi will implement changes in the
configuration of its Executive Committee. This leadership committee
will now include, in addition to the four GBU Heads, the global
Heads of R&D, Industrial Affairs, Finance, Human Resources and
Legal, together with the Chief Digital Officer. A leaner
configuration will foster agility and speed in decision-making, in
line with the fourth priority of the company’s new strategy
(“Reinvent How We Work”).
The table below presents sales by Global
Business Unit (GBU).
Net Sales by GBU
(€ million) |
Q4 2019 |
Change at CER |
2019 |
Change at CER |
Sanofi Genzyme (Specialty Care)(a) |
|
2,525 |
|
+19.7% |
9,195 |
+22.4%(c) |
Primary Care(a) |
|
2,325 |
|
-8.7% |
9,076 |
-14.8%(d) |
China & Emerging Markets(b) |
|
1,698 |
|
-1.9% |
7,437 |
+6.4% |
Total
Pharmaceuticals |
|
6,548 |
|
+2.4% |
25,708 |
+2.2% |
Consumer Healthcare
(CHC) |
|
1,152 |
|
-5.2% |
4,687 |
-0.8% |
Sanofi Pasteur
(Vaccines) |
|
1,908 |
|
+22.0% |
5,731 |
+9.3% |
Total net sales |
|
9,608 |
|
+4.7% |
36,126 |
+2.8%(e) |
(a) Does not include China & Emerging Markets sales
- see definition page 9; (b) Includes Emerging Markets sales for
Primary Care and Specialty Care; (c) +19.3% at CS -Adjusted for
Bioverativ acquisition and sales of Bioverativ products to SOBI –
see page 5; (d) -10.9% at CS; (e) +3.6% at CS - Adjusted for
Bioverativ and sales of Bioverativ products to SOBI and disposal of
European Generics business.
Global
Franchises
The tables below present fourth-quarter
and full-year 2019 sales by global franchise, including Emerging
Markets sales, to facilitate comparisons. Appendix 1 provides a
reconciliation of sales by GBU and franchise.
Net sales by Franchise (€
million) |
Q4 2019 |
Change at CER |
Developed Markets |
Change at CER |
EmergingMarkets |
Change at CER |
Specialty Care
franchises |
2,830 |
+18.9% |
2,525 |
+19.7% |
305 |
+12.8% |
Rare Disease |
815 |
+1.6% |
661 |
+0.8% |
154 |
+5.3% |
Multiple Sclerosis |
540 |
-3.0% |
517 |
-3.8% |
23 |
+21.1% |
Oncology |
441 |
+11.4% |
333 |
+12.6% |
108 |
+7.9% |
Immunology |
733 |
+128.6% |
721 |
+126.2% |
12 |
ns |
Rare Blood Disorder |
301 |
-0.7% |
293 |
-2.4% |
8 |
ns |
Primary Care
franchises |
3,718 |
-7.2% |
2,325 |
-8.7% |
1,393 |
-4.7% |
Established Rx Products |
2,276 |
-6.3% |
1,299 |
-4.0% |
977 |
-9.3% |
Diabetes |
1,268 |
-9.2% |
861 |
-15.5% |
407 |
+7.4% |
Cardiovascular |
174 |
-4.5% |
165 |
-5.8% |
9 |
+33.3% |
Consumer Healthcare |
1,152 |
-5.2% |
727 |
-9.4% |
425 |
+3.0% |
Vaccines |
1,908 |
+22.0% |
1,356 |
+25.5% |
552 |
+14.2% |
Total net sales |
9,608 |
+4.7% |
6,933 |
+5.9% |
2,675 |
+1.8% |
(6) See Appendix 11 for definitions of
financial indicators. (7) subject to consultation with social
partners and works councils.
Net sales by Franchise (€
million) |
2019 |
Change at CER |
Developed Markets |
Change at CER |
EmergingMarkets |
Change at CER |
Specialty Care
franchises |
10,431 |
+22.7%(1) |
9,195 |
+22.4% |
1,236 |
+24.4% |
Rare Disease |
3,165 |
+6.5% |
2,551 |
+2.6% |
614 |
+24.0% |
Multiple Sclerosis |
2,160 |
+1.8% |
2,080 |
+1.3% |
80 |
+14.7% |
Oncology |
1,695 |
+10.6% |
1,205 |
+8.3% |
490 |
+16.7% |
Immunology |
2,259 |
+148.1% |
2,228 |
+146.1% |
31 |
ns |
Rare Blood Disorder |
1,152 |
+22.0%(2) |
1,131 |
+20.0%(3) |
21 |
ns |
Primary Care
franchises |
15,277 |
-8.2%(4) |
9,076 |
-14.8%(5) |
6,201 |
+3.3% |
Established Rx Products(6) |
9,559 |
-8.3%(7) |
5,088 |
-15.0%(8) |
4,471 |
+0.6% |
Diabetes |
5,113 |
-8.2% |
3,412 |
-15.6% |
1,701 |
+10.3% |
Cardiovascular |
605 |
-4.6% |
576 |
-6.4% |
29 |
+55.6% |
Consumer Healthcare |
4,687 |
-0.8% |
3,035 |
-3.6% |
1,652 |
+4.7% |
Vaccines |
5,731 |
+9.3% |
3,906 |
+3.4% |
1,825 |
+24.0% |
Total net sales |
36,126 |
+2.8%(9) |
25,212 |
+0.4%(10) |
10,914 |
+8.7% |
(1) +19.9 % at CS- Adjusted for
Bioverativ and sales of products to SOBI – see page 5; (2) +0.8% at
CS- see page 5; (3) -0.8% at CS -see page 5; (4) -5.5% at CS; (5)
-10.9% at CS; (6) including Generics; (7) -4.1% at CS; (8) -7.9% at
CS; (9) +3.6% at CS- Adjusted for Bioverativ and sales of
Bioverativ products to SOBI and disposal of European Generics
business;(10) +1.5% at CS - Adjusted for Bioverativ and sales of
Bioverativ products to SOBI and disposal of European Generics
business.
Pharmaceuticals
Fourth-quarter Pharmaceutical sales were
up 2.4% to €6,548 million, mainly driven by Dupixent® which was
partially offset by Diabetes and Established Rx Products. Full-year
2019 sales for Pharmaceuticals increased 2.2% (up 3.3% at CS) to
€25,708 million, reflecting the disposal of the European generics
business at the end of the third quarter of 2018.
Specialty Care
franchises
Immunology franchise
Net sales (€
million) |
Q4 2019 |
Change at CER |
2019 |
Change at CER |
Dupixent® |
679 |
+135.4% |
2,074 |
+151.6% |
Kevzara® |
54 |
+67.7% |
185 |
+114.5% |
Total
Immunology |
733 |
+128.6% |
2,259 |
+148.1% |
Dupixent®
(collaboration with Regeneron) generated sales of €679 million in
the fourth quarter (up 135%). In the U.S., Dupixent® sales of €545
million (up 135%) were driven by continued growth in atopic
dermatitis which benefited from increased penetration in adult
patients and launch in the adolescent age group (12 to 17 years of
age) in March, together with rapid uptake in asthma and launch in
chronic rhinosinusitis with nasal polyposis (CRSwNP, approved in
June). In the U.S., Dupixent® NBRx and TRx more than doubled in the
quarter compared to the fourth quarter of 2018, growing at 108% and
117%, respectively. Fourth-quarter sales of Dupixent® in Europe
rose to €64 million (up 117%) following additional launches while
sales in Japan were €46 million (versus €13 million in the fourth
quarter of 2018). Full-year 2019 Dupixent® sales increased 152% to
€2,074 million. Dupixent® is now launched in 34 countries for adult
atopic dermatitis; among these, Dupixent® is also launched in
adolescent atopic dermatitis in 10 countries, in asthma in 8
countries and in CRSwNP in 4 countries. Potentially as many as 89
additional country launches are planned across these indications
for 2020.
Kevzara® (collaboration
with Regeneron) sales were €54 million (up 68%) in the fourth
quarter, of which €34 million was generated in the U.S. (up 39%).
Full-year 2019 Kevzara® sales increased 114% to €185
million.
Multiple Sclerosis
franchise
Net sales (€
million) |
Q4 2019 |
Change at CER |
2019 |
Change at CER |
Aubagio® |
482 |
+5.4% |
1,879 |
+10.0% |
Lemtrada® |
58 |
-41.7% |
281 |
-31.6% |
Total Multiple
Sclerosis |
540 |
-3.0% |
2,160 |
+1.8% |
Fourth-quarter Multiple
Sclerosis (MS) sales decreased 3.0% to €540 million. Over
the period, Aubagio® sales growth in the U.S. was more than offset
by lower Lemtrada® sales. Full-year 2019 MS sales increased 1.8% to
€2,160 million.
Fourth-quarter Aubagio®
sales increased 5.4% to €482 million, driven by the U.S.
performance (up 7.1% to €343 million). Full-year 2019 Aubagio®
sales increased 10.0% to €1,879 million. As of January 1, Aubagio®
was excluded from the national formulary at ESI, which covers
roughly 14% of total commercial lives in the US. Contracted access
positions for Aubagio® remain strong for other national health
plans and national PBMs.
In the fourth quarter,
Lemtrada® sales decreased 42% to €58 million due
to lower sales in the U.S. (down 29% to €34 million) and in Europe
(down 57% to €16 million), reflecting increased global competition
and the update to the EU label. Full-year 2019 Lemtrada® sales
decreased 32% to €281 million.
Oncology franchise
Net sales (€
million) |
Q4 2019 |
Change at CER |
2019 |
Change at CER |
Jevtana® |
128 |
+9.6% |
484 |
+11.1% |
Thymoglobulin® |
89 |
+12.8% |
354 |
+16.5% |
Eloxatin® |
42 |
-4.7% |
203 |
+10.4% |
Mozobil® |
55 |
+12.8% |
198 |
+11.7% |
Taxotere® |
42 |
+10.5% |
173 |
+3.0% |
Zaltrap® |
26 |
+8.7% |
97 |
+4.4% |
Others |
59 |
+29.5% |
186 |
+9.1% |
Total
Oncology |
441 |
+11.4% |
1,695 |
+10.6% |
Fourth-quarter Oncology
sales increased 11.4% to €441 million driven by the U.S. (up 18.4%
to €174 million) and Europe (up 15.7% to €102 million). Full-year
2019 Oncology sales increased 10.6% to €1,695 million.
Fourth-quarter Jevtana®
sales increased 9.6% to €128 million driven by the U.S. and by
publication of the results of the CARD study in metastatic
castration-resistant prostate cancer at ESMO (European Society for
Medical Oncology) in September 2019. Full-year 2019 Jevtana® sales
were up 11.1% to €484 million. In the fourth quarter,
Thymoglobulin® sales increased 12.8% to €89
million, driven by the U.S. 2019 sales of Thymoglobulin®
increased 16.5% to €354 million.
Libtayo® (collaboration
with Regeneron) approved for the treatment of patients with
metastatic cutaneous squamous cell carcinoma (CSCC) or locally
advanced CSCC who are not candidates for curative surgery or
curative radiation had ex-U.S. sales of €12 million and €16 million
in the fourth quarter and full-year 2019, respectively. In 2019
Libtayo® was launched in 7 countries outside the U.S. and there are
13 additional country launches planned by the end of 2020. U.S.
Libtayo® sales are reported by Regeneron.
Rare Disease franchise
Net sales (€ million) |
Q4 2019 |
Change at CER |
2019 |
Change at CER |
Myozyme® / Lumizyme® |
238 |
+4.4% |
918 |
+8.3% |
Fabrazyme® |
215 |
+2.4% |
813 |
+5.3% |
Cerezyme® |
177 |
-6.8% |
708 |
+2.7% |
Aldurazyme® |
54 |
0.0% |
224 |
+9.2% |
Cerdelga® |
55 |
+22.7% |
206 |
+26.4% |
Others Rare Disease |
76 |
+1.4% |
296 |
+0.7% |
Total Rare Disease |
815 |
+1.6% |
3,165 |
+6.5% |
In the fourth quarter, Rare
Disease sales increased 1.6% to €815 million against a
high base for comparison. This performance was driven by Emerging
Markets (up 5.3% to €154 million) and the U.S. (up 2.7% to €309
million). In Europe, over the period, sales were flat at €263
million. Full-year 2019 Rare Disease sales increased 6.5% to €3,165
million.
Fourth-quarter Gaucher
(Cerezyme® and Cerdelga®) sales decreased 1.3% to
€232 million, impacted by Cerezyme® sales phasing effects in
Emerging Markets which offset strong Cerdelga® performance.
Fourth-quarter Cerdelga® sales increased 22.7% to €55 million, with
sales up 18.8% in Europe (to €20 million) and up 19.2% in the U.S.
(to €31 million). Full-year 2019 Gaucher sales were €914 million,
up 7.0%.Fourth-quarter Pompe
(Myozyme®/Lumizyme®)
sales grew 4.4% to €238 million, driven by the U.S. (up 7.6% to €88
million) and Emerging Markets (up 16.7% to €41 million) and
supported by positive trends in naïve patient accrual. Full-year
2019 Myozyme®/Lumizyme® sales increased 8.3% to €918
million.
Fourth-quarter Fabry
(Fabrazyme®) sales grew 2.4% to €215 million,
driven by Emerging Markets (up 15.4% to €29 million) and Europe (up
6.7% to €48 million). Over the period, U.S. sales decreased 1.0% to
€106 million. Full-year 2019 Fabrazyme® sales were up 5.3% to €813
million.
Rare Blood Disorder
franchise
Net sales (€
million) |
Q4 2019 |
Change at CER |
2019 |
Change at CER |
Eloctate® |
177 |
-12.8% |
684 |
+6.6%* |
Alprolix® |
108 |
+9.5% |
412 |
+37.2%** |
Cablivi® |
16 |
ns |
56 |
ns |
Total
Rare Blood Disorder |
301 |
-0.7% |
1,152 |
+22.0%*** |
* -11.6% at CS in 2019 - see footnote 8; **+12.4% at CS
in 2019 – see footnote 8; *** +0.8% at CS in 2019 - see
footnote 8
Bioverativ was consolidated in Sanofi’s
Financial Statements from March 9, 2018. Fourth-quarter sales of
the Rare Blood Disorder franchise were €301 million, down 0.7%.
Fourth-quarter U.S. sales were €210 million, down 13.6%. Non U.S.
sales were €91 million with Japan as the primary contributor.
Full-year 2019 sales of the Rare Blood Disorder franchise were
€1,152 million, up 0.8% at CS(8).
Eloctate® sales were
€177 million in the fourth quarter, down 12.8%. In the U.S., sales
of the product decreased 25.6% to €123 million, reflecting ongoing
competitive pressure. In the Rest of the World region,
fourth-quarter Eloctate® sales increased 35.3% to €47 million.
Full-year 2019 Eloctate® sales were €684 million, down 11.6% at
CS(8).
Alprolix® sales were
€108 million in the fourth quarter, up 9.5%. In the U.S., sales of
the product decreased 1.3% to €77 million, related to
shipment timing. In the Rest of the World region, Alprolix® sales
increased 47.4% to €30 million due to growth in product sales to
SOBI. Full-year 2019 Alprolix® sales were €412 million, up 12.4% at
CS(8).
Cablivi® for the
treatment of adults with acquired thrombotic thrombocytopenic
purpura (aTTP) generated fourth-quarter sales of €16 million. The
number of patients treated with Cablivi increased over 30% compared
to the third quarter to approximately 150 patients. Sales were
sequentially lower primarily due to price adjustments in Europe and
increased assistance program participations in the U.S. In the
U.S., where Cablivi® was launched in April, sales were €10 million.
In Europe, the product is commercially available in Germany,
Denmark, Austria, Belgium and the Netherlands. Cablivi® has a
temporary license to be sold in France. Full-year 2019 Cablivi®
sales were €56 million.
Primary Care
franchises
Cardiovascular franchise
Net sales (€
million) |
Q4 2019 |
Change at CER |
2019 |
Change at CER |
Praluent® |
75 |
-11.0% |
258 |
-3.8% |
Multaq® |
99 |
+1.1% |
347 |
-5.1% |
Total
cardiovascular franchise |
174 |
-4.5% |
605 |
-4.6% |
Fourth-quarter
Praluent® (collaboration with Regeneron) sales
decreased 11.0% to €75 million, reflecting lower sales in the U.S.
(down 26.9% to €39 million) which were impacted by significantly
higher rebates. In Europe, Praluent® sales increased 4.3% to €24
million despite the suspension of sales in Germany in August
following the Regional Court of Dusseldorf ruling in the ongoing
patent litigation. Full-year 2019 Praluent® sales decreased 3.8% to
€258 million.
In December 2019, Sanofi and Regeneron
announced their intent to simplify their antibody collaboration for
Kevzara® and Praluent® by restructuring into a royalty-based
agreement. Under the proposed restructuring, Sanofi is expected to
gain sole global rights to Kevzara® and sole ex-U.S. rights to
Praluent®. Regeneron is expected to gain sole U.S. rights to
Praluent®. Under the proposed terms of the agreement, each party
will be solely responsible for funding development and
commercialization expenses in their respective territories. These
changes are expected to increase efficiency and streamline
operations for the products. Completion of the agreement is
expected to be finalized in the first quarter of 2020.
(8) Growth comparing 2019 sales versus
full 2018 sales at CER. Sales of products to SOBI were initially
recorded in “other revenues” in H1 2018 and in sales from H2 2018;
the H1 2018 reclassification was reflected in Q3 2018. H1 2018 and
Q3 2018 sales were adjusted accordingly for calculation of CS.
Unaudited data..Diabetes
franchise
Net sales (€
million) |
Q4 2019 |
Change at CER |
2019 |
Change at CER |
Lantus® |
729 |
-17.2% |
3,012 |
-17.0% |
Toujeo® |
234 |
+8.5% |
883 |
+3.2% |
Total glargine |
963 |
-12.2% |
3,895 |
-13.2% |
Amaryl® |
79 |
0.0% |
334 |
-2.1% |
Apidra® |
88 |
-2.2% |
344 |
-3.6% |
Admelog® |
56 |
-1.8% |
250 |
+155.9% |
Soliqua® |
39 |
+40.7% |
122 |
+60.3% |
Insuman® |
20 |
-13.0% |
82 |
-7.7% |
Total Diabetes |
1,268 |
-9.2% |
5,113 |
-8.2% |
In the fourth quarter, global
Diabetes sales decreased 9.2% to €1,268 million,
due to lower glargine (Lantus® and Toujeo®) sales in the U.S.
Fourth-quarter U.S. Diabetes sales were down 20.5% to €454
million, reflecting the increased contribution to the coverage gap
related to Medicare Part D and a continued decline in average U.S.
glargine net prices. Fourth-quarter sales in Emerging Markets
increased 7.4% to €407 million. Fourth-quarter sales in Europe
decreased 4.4% to €305 million despite Toujeo® growth. Full-year
2019 global Diabetes sales decreased 8.2% to €5,113 million. Broad
U.S. payer coverage for key Diabetes brands is expected to be
largely maintained in 2020.
In the fourth quarter,
Lantus® sales were €729 million, down 17.2%. In
the U.S., Lantus® sales decreased 26.9% to €286 million, mainly
reflecting lower average net price and the increased contribution
to the coverage gap related to Medicare Part D. In Europe,
fourth-quarter Lantus® sales were €146 million, down 13.1% due to
biosimilar glargine competition and patients switching to Toujeo®.
In Emerging Markets, fourth-quarter Lantus® sales were stable at
€244 million reflecting lower sales in the Middle-East. Full-year
2019 Lantus® sales decreased 17.0% to €3,012
million.On January 28, 2020, Sanofi’s petition for
rehearing the Court of Appeals for the Federal Circuit decision
affirming the December 2018 PTAB decisions invalidating the Lantus®
formulation patents was denied. Mylan currently does not have FDA
approval for either its vial or pen product.
Fourth-quarter Toujeo®
sales increased 8.5% to €234 million. In the U.S., fourth-quarter
Toujeo® sales were €77 million, down 7.4% mainly reflecting lower
average net price and the increased contribution to the coverage
gap related to Medicare Part D. In Europe and Emerging Markets,
fourth-quarter Toujeo® sales were €87 million (up 14.3%) and €48
million (up 48.4%), respectively. Full-year 2019 Toujeo® sales
increased 3.2% to €883 million.
Fourth-quarter and full-year 2019
Amaryl® sales were €79 million (stable) and €334
million (down 2.1%), respectively. In China, the second wave of the
nationwide VBP (volume-based procurement) program includes
glimepiride in 2020 and Sanofi has opted not to bid with Amaryl®.
In China, Amaryl® sales were €136 million (up 3.1%) in 2019. Sanofi
expects sales of Amaryl® in China to decline significantly in 2020
due to the extended VBP program.
Fourth-quarter Apidra®
sales decreased 2.2% to €88 million. Lower sales in the U.S. (down
47.1% to €10 million) offset growth in Emerging Markets (up 20.7%
to €34 million). Full-year 2019 Apidra® sales were €344 million,
down 3.6%.
Admelog® (insulin
lispro injection) generated sales of €56 million (down 1.8%) in the
fourth quarter. Admelog® sales in the U.S. were €52 million, down
7.4% due to the WAC price adjustment of -44% which took effect on
July 1, 2019. Full-year 2019 Admelog® sales were €250 million
versus €93 million in 2018. Sanofi expects lower Admelog® sales in
2020 due to the full-year impact of the U.S. WAC price
adjustment.
Fourth-quarter and full-year 2019
Soliqua® 100/33 (insulin glargine 100 Units/mL
& lixisenatide 33 mcg/mL injection) and
Suliqua™ sales increased 41% (to €39 million) and
60% (to €122 million), respectively.
Established Rx
Products
Net sales (€
million) |
Q4 2019 |
Change at CER |
2019 |
Change at CER |
Lovenox® |
335 |
-4.0% |
1,359 |
-7.4% |
Plavix® |
212 |
-36.9% |
1,334 |
-8.8% |
Aprovel®/Avapro® |
131 |
-15.2% |
674 |
+2.0% |
Synvisc® /Synvisc-One® |
81 |
-1.2% |
309 |
-5.1% |
Renvela®/Renagel® |
82 |
-15.6% |
311 |
-26.5% |
Myslee®/Ambien®/Stilnox® |
56 |
-6.8% |
219 |
-7.8% |
Allegra® |
28 |
0.0% |
128 |
-2.4% |
Generics |
271 |
-0.4% |
1,075 |
-27.9% |
Other |
1,080 |
+2.7% |
4,150 |
-1.8% |
Total Established Rx
Products |
2,276 |
-6.3% |
9,559 |
-8.3% |
In the fourth quarter,
Established Rx Products sales decreased 6.3% to
€2,276 million, primarily reflecting the decline in Plavix® and
Aprovel® family sales in China due to net price adjustments and
inventory reduction in the channel following the nationwide
implementation of the VBP program in December. Full-year 2019
Established Rx Products sales decreased 8.3% to €9,559 million
(down 4.1% at CS) reflecting divestment of the European generics
business at the end of the third quarter of 2018.
Fourth-quarter Lovenox®
sales decreased 4.0% to €335 million, reflecting lower Mature
Markets sales (down 14.4% to €197 million) due to biosimilar
competition in several countries in Europe. In Emerging Markets,
Lovenox® sales grew 16.2% to €138 million. Full-year 2019 Lovenox®
sales were down 7.4% to €1,359 million.
In the fourth quarter,
Plavix® sales were down 36.9% to €212 million,
primarily reflecting the decrease in China (sales down 69.1% to €55
million) due to net price adjustments and inventory reduction in
the channel following the nationwide implementation of the VBP
program in December. In Japan, Plavix® sales decreased 21.1% to €32
million due to a price reduction in October 2019. Full-year 2019
Plavix® sales decreased 8.8% to €1,334 million.
Fourth-quarter
Aprovel®/Avapro® sales were down 15.2% to €131
million, primarily reflecting the decrease in China (sales down
40.6% to €40 million) due to net price adjustments and inventory
reduction in the channel following nationwide implementation of the
VBP program in December. Full-year 2019 Aprovel®/Avapro® sales
increased 2.0% to €674 million.
As previously announced, Sanofi expects
sales of Plavix® and the Aprovel® family in China to decline by
around 50% in 2020 due to implementation of the VBP
program.
Fourth-quarter
Renvela®/Renagel® (sevelamer) sales decreased
15.6% to €82 million, due to generic competition in the U.S. (down
40.4% to €35 million) and despite growth in China. Full-year 2019
Renvela®/Renagel® sales decreased 26.5% to €311
million.
In the fourth quarter,
Generics sales decreased 0.4% to €271 million,
including stable sales in Emerging Markets (at €172 million).
Full-year 2019 Generics sales were €1,075 million, down 27.9% (up
3.9% at CS), reflecting the divestment of the European generics
business at the end of the third quarter of 2018.
Consumer
Healthcare
CHC sales by geography and category are
provided in Appendix 1.
Net sales (€
million) |
Q4 2019 |
Change at CER |
2019 |
Change at CER |
Allergy Cough & Cold |
281 |
+1.9% |
1,179 |
+2.2% |
of which Allegra® |
95 |
+16.3% |
436 |
+6.1% |
of which Mucosolvan® |
28 |
-6.7% |
99 |
-10.9% |
of which Xyzal® |
12 |
+10.0% |
51 |
+17.1% |
Pain |
329 |
-2.4% |
1,259 |
+1.3% |
of which Doliprane® |
95 |
-3.1% |
324 |
-3.0% |
of which Buscopan® |
50 |
+8.2% |
189 |
+7.7% |
Digestive |
227 |
-13.3% |
1,004 |
0.0% |
of which Dulcolax® |
54 |
-3.6% |
225 |
+2.8% |
of which Enterogermina® |
53 |
+10.6% |
222 |
+20.2% |
of which Essentiale® |
49 |
-2.1% |
190 |
+5.6% |
of which Zantac® |
-5 |
ns |
78 |
-42.5% |
Nutritionals |
165 |
-7.5% |
657 |
-4.1% |
Other |
150 |
-7.5% |
588 |
-8.2% |
of which Gold Bond® |
64 |
-9.0% |
213 |
-4.3% |
Total Consumer
Healthcare |
1,152 |
-5.2% |
4,687 |
-0.8% |
In the fourth quarter, Consumer
Healthcare (CHC) sales decreased 5.2% to €1,152 million.
Over half of the decline was related to the voluntary recall of
Zantac®. In addition, divestments of non-core products and product
suspensions due to changing regulatory requirements impacted sales
performance. These factors are expected to have a dampening effect
on CHC performance through the first half of 2020. Full-year 2019
CHC sales decreased 0.8% to €4,687 million.
In September 2019, the U.S. Food and
Drug Administration (FDA) and Health Canada issued public
statements alerting that some ranitidine medicines, including
Zantac® OTC, could contain NDMA at low levels and asked
manufacturers to conduct testing. Evaluations are ongoing on both
drug substance (active ingredient) and finished drug product. Due
to inconsistencies in preliminary test results of the active
ingredient used in the U.S. and Canadian products, Sanofi decided
to conduct the voluntary recall in the U.S. and Canada in October
2019.
In Europe, fourth-quarter CHC sales
decreased 11.7% to €325 million, impacted by changing regulatory
requirements as well as divestments of non-strategic brands.
Full-year 2019 CHC sales in Europe were down 6.4% to €1,311
million.
In the U.S., fourth-quarter CHC
sales decreased 12.8% to €246 million, reflecting the impact of the
Zantac® recall. In the fourth quarter, Zantac® sales were -€3m
compared to €31 million in the fourth quarter of 2018, reflecting
the recall as well as additional provisions for returns. Full-year
2019 CHC sales in the U.S. were down 3.6% to €1,086 million.
In Emerging Markets,
fourth-quarter CHC sales increased 3.0% to €425 million, driven by
performance in Asia. Full-year 2019 CHC sales in Emerging Markets
increased 4.7% to €1,652 million.
In the Rest of the
World, fourth-quarter CHC sales increased 2.7% to €156
million, driven by the strong performance of Allegra® in
Japan.
Vaccines
Net sales (€
million) |
Q4 2019 |
Change at CER |
2019 |
Change at CER |
Polio/Pertussis/Hib vaccines (incl.
Hexaxim® / Hexyon®, Pentacel®, Pentaxim® and Imovax®) |
443 |
-13.7% |
1,946 |
+9.8% |
Influenza vaccines(incl. Vaxigrip®,
Fluzone HD®, Fluzone® & Flublok®) |
1,039 |
+69.1% |
1,891 |
+7.3% |
Meningitis/Pneumo vaccines (incl.
Menactra®) |
124 |
-6.1% |
682 |
+8.4% |
Adult Booster vaccines (incl. Adacel
®) |
147 |
+6.7% |
563 |
+16.2% |
Travel and other endemic vaccines |
123 |
-7.7% |
539 |
+8.4% |
Other vaccines |
32 |
+6.5% |
110 |
+13.8% |
Total Vaccines |
1,908 |
+22.0% |
5,731 |
+9.3% |
Fourth-quarter Vaccines
sales increased 22.0% to €1,908 million as the majority of U.S.
influenza vaccines shipments occurred in the quarter, reflecting
the delay in strain selection by the WHO at the beginning of the
year. As a consequence, U.S. fourth-quarter Vaccines sales were up
33.1% to €1,002 million. In Europe and Emerging Markets,
fourth-quarter Vaccines sales were up 15.1% (to €275 million) and
up 14.2% (to €552 million), respectively, also driven by influenza
vaccines performance. Full-year 2019 Vaccines sales were up 9.3% to
€5,731 million.
In the fourth quarter,
Polio/Pertussis/Hib (PPH) vaccines sales decreased
13.7% to €443 million, reflecting unfavorable delivery phasing of
Hexaxim® in Emerging Markets. Fourth-quarter
Emerging Markets PPH vaccines sales were down 16.4% to €243
million. In the U.S., PPH vaccines sales were up 3.9% to €110
million in the fourth quarter driven by Pentacel®.
In Europe, over the period, PPH vaccines sales were down 9.6% to
€75 million due to unfavorable delivery phasing on pediatric
vaccines. Full-year 2019 PPH vaccines sales were up 9.8% to €1,946
million.
Influenza vaccines
sales increased 69.1% to €1,039 million in the fourth quarter, as
the majority of U.S. influenza vaccines shipments occurred in the
quarter (up 65.7% to €705 million). U.S. performance also benefited
from successful influenza differentiation strategy. Over the
period, influenza vaccines sales in Europe (up 40.9% to €130
million) and in Emerging Markets (up 139% to €163 million)
benefited from further quadrivalent vaccines penetration as well as
an increase in vaccination coverage rates. Full-year 2019 influenza
vaccines sales increased 7.3% to €1,891 million. U.S. influenza
vaccines sales were stable (up 0.2%) in 2019 as a result of
reserves for estimated higher returns, reflecting the later timing
of supply compared with the previous year.
Fourth-quarter
Menactra® sales decreased 5.4% to €124 million,
reflecting order phasing in the U.S. and continued expansion in
Emerging markets. Full-year 2019 Menactra® sales increased 8.6% to
€682 million.
Fourth-quarter Travel and other
endemic vaccines sales were €123 million, down 7.7%,
reflecting lower rabies vaccines sales. Full-year 2019 Travel and
other endemic vaccines sales were up 8.4% to €539
million.
Fourth-quarter Adult
Booster vaccines sales were up 6.7% to €147 million,
driven by performance in Europe (up 18.2% to €39 million) and
Emerging Markets (up 50.0% to €27 million). In the US., over the
period, Adult Booster vaccines were down 5.3% to €74 million,
reflecting delivery phasing for Adacel®. Full-year
2019 Adult Booster vaccines sales increased 16.2% to €563
million.
Company sales by geographic
region
Sanofi sales (€
million) |
Q4 2019 |
Change at CER |
2019 |
Change at CER |
United States |
3,684 |
+11.8% |
12,756 |
+5.0% |
Emerging Markets(a) |
2,675 |
+1.8% |
10,914 |
+8.7% |
of which Asia |
883 |
-9.0% |
4,393 |
+8.5% |
of which Latin America |
744 |
+7.5% |
2,734 |
+11.2% |
of which Africa, Middle East |
634 |
+3.2% |
2,307 |
+1.7% |
of which Eurasia(b) |
360 |
+19.8% |
1,312 |
+17.2% |
Europe(c) |
2,344 |
0.0% |
8,852 |
-6.1% |
Rest of the
World(d) |
905 |
+0.6% |
3,604 |
+2.8% |
of which Japan |
455 |
+0.5% |
1,908 |
+4.6% |
Total Sanofi sales |
9,608 |
+4.7% |
36,126 |
+2.8% |
- World excluding U.S., Canada, Western & Eastern
Europe (except Eurasia), Japan, South Korea, Australia, New Zealand
and Puerto Rico
- Russia, Ukraine, Georgia, Belarus, Armenia and
Turkey
- Western Europe + Eastern Europe except
Eurasia
- Japan, South Korea, Canada, Australia, New Zealand,
Puerto Rico
Fourth-quarter sales in the
U.S. increased 11.8% to €3,684 million, reflecting
strong Dupixent® performance and quarterly phasing of influenza
vaccines shipments. Full-year 2019 U.S. sales increased 5.0% to
€12,756 million.
Fourth-quarter sales in Emerging
Markets rose 1.8% to €2,675 million as growth in Vaccines
(up 14.2%) and Diabetes (up 7.4%) was largely offset by lower sales
of Established Rx Products (down 9.3%). In Asia, fourth-quarter
sales were down 9.0% to €883 million, due to lower sales in China
(down 21.0% to €453 million), mainly reflecting the impact of the
VBP program. In Latin America, fourth-quarter sales increased 7.5%
to €744 million driven by Mexico performance. Fourth-quarter sales
in Brazil were up 2.4% to €249 million. In Africa and the Middle
East region, fourth-quarter sales were up 3.2% to €634 million,
mainly reflecting order phasing. Fourth-quarter sales in the
Eurasia region increased 19.8% to €360 million, supported by strong
growth in Turkey. Fourth-quarter sales in Russia were €168 million,
up 1.3%. In Emerging Markets, full-year 2019 sales increased 8.7%
to €10,914 million. In 2019, sales in China, Brazil and Russia were
€2,704 million (up 8.8%), €1,013 million (up 1.6%) and €673 million
(up 9.1%), respectively.
Fourth-quarter sales in
Europe were stable at €2,344 million. Over the
period, Dupixent® and Vaccines performance were offset by lower
Lovenox®, Lemtrada®, Lantus® and CHC sales. In Europe, full-year
2019 sales decreased 6.1% (-1.3% at CS) to €8,852 million,
reflecting divestment of the European generics business at the end
of the third quarter of 2018.
Sales in Japan increased 0.5%
to €455 million in the fourth quarter, driven by Dupixent® which
offset lower sales of Plavix® and Vaccines. In Japan, full-year
2019 sales increased 4.6% to €1,908 million.
R&D
update
Consult Appendix 9
for full overview of Sanofi’s R&D pipeline |
Regulatory update
Regulatory updates since October 31,
2019 include the following:
- In November, Dupixent® (collaboration
with Regeneron) was submitted to the FDA in children 6 to 11 years
with moderate-to-severe atopic dermatitis.The FDA has granted a
priority review and set a PDUFA date of May 26, 2020. Dupixent® was
also submitted for the same indication in the European Union in
January.
- In November, the FDA approved a supplemental NDA
expanding the indication for Toujeo® in the United
States to include the treatment of pediatric patients 6 years and
older with diabetes.
- In November, the FDA approved a supplemental Biologics
License Application for Fluzone® High-Dose
Quadrivalent (influenza vaccine) for use in adults 65 years of age
and older.
- In December, the China National Medical Products
Administration (NMPA) approved Praluent® for the
treatment of adult patients with primary hypercholesterolaemia or
mixed dyslipidemia and for the treatment of adult patients with
established atherosclerotic cardiovascular disease to reduce
myocardial infarction, stroke or unstable angina requiring
hospitalization.
- In December, the China National Medical Products
Administration (NMPA) approved Fabrazyme® as a
long term enzyme replacement therapy in patients with confirmed
diagnosis of Fabry disease.
- In January, the European Commission approved the
expansion of the indication for Toujeo® in the
European Union to include the treatment of diabetes in adolescents
and children (6 years and older).
At the beginning of February 2020, the
R&D pipeline contained 91 projects, including 38 new molecular
entities in clinical development (or that have been submitted to
the regulatory authorities). 39 projects are in phase 3 or have
been submitted to the regulatory authorities for
approval.
Portfolio update
Phase 3:
- Three-year data from the OLE (Open Label Extension)
study of Dupixent® supporting the long term
efficacy and safety profile were presented at the Maui Dermatology
Conference in January.
- Positive results of a pivotal phase 3 open-label,
single-arm trial evaluating the safety and efficacy of
sutimlimab in people with primary cold agglutinin
disease (CAD) were presented at the Late Breaking Abstracts Session
of the Annual Meeting of the American Society of Hematology. This
study met its primary and secondary endpoints.
- Positive results from the EDITION JUNIOR phase 3 trial,
evaluating Toujeo® in children and adolescents
with type 1 diabetes, were presented at the International Society
for Pediatric and Adolescent Diabetes Annual
Conference.
- SAR408701, an anti-CEACAM5
antibody-drug conjugate, entered into phase 3 in second and third
line non-small cell lung cancer (NSCLC).
- Dupixent® entered into phase 3 in
bullous pemphigoid, chronic spontaneous urticaria and prurigo
nodularis.
- BIVV001 (recombinant coagulation
factor VIII Fc) entered into phase 3 in hemophilia A.
Phase 2
- BTK inhibitor, SAR442168, met the
primary endpoint in a proof of concept trial in relapsing multiple
sclerosis, with detailed results expected to be presented at an
upcoming medical meeting in Q2 2020.
- Olipudase alfa, a recombinant human
acid sphingomyelinase, demonstrated positive results in two
separate clinical trials evaluating olipudase alfa for the
treatment of acid sphingomyelinase deficiency (ASMD) in adult and
pediatric patients. Olipudase alfa is the first and only
investigational enzyme replacement therapy in late-stage
development for the treatment of ASMD. No treatments are currently
approved for ASMD.
- SAR439859, a selective estrogen
receptor degrader (SERD), has entered into a pivotal phase 2 study
in second and third line metastatic breast cancer as a monotherapy,
a phase 2 study to enable examination in the adjuvant setting, and
a phase 1 combination with palbociclib.
Phase 1
- A candidate vaccine for Yellow Fever entered into
phase 1.
- THOR-707, an engineered “not-alpha”
IL-2, entered into phase 1 for the treatment of solid tumors, with
the acquisition of Synthorx.
- SAR441000, an mRNA-based intratumoral
immunotherapy, entered into phase1 in combination with
PD-1.
Synthorx
- On January 23, Sanofi
announced the completion of its acquisition of Synthorx, enhancing
Sanofi’s position as an emerging leader in the area of oncology and
immunology. Through the acquisition Sanofi gained access to
THOR-707 and an innovative platform that complements the company’s
oncology and immunology research.
Sustainable performance
update
Sanofi’s leadership in water management
was recently recognized by CDP in its rating upgrade to A- from B.
CDP is a global non-profit organization that drives companies and
governments to reduce greenhouse gas emissions, safeguard water
resources.
Sanofi considers water as a sustainable
renewable resource and believes that shortages of water could
become a major obstacle to public health involving diseases
associated with lack of access to safe drinking water, inadequate
sanitation and poor hygiene. Consequently the company has
implemented a dedicated program to reduce water consumption and
promote its reuse. Sanofi has already exceeded its 2020 target to
reduce water consumption.
2019 fourth-quarter and
full-year 2019 financial results(9)
Business Net
Income(9)
In the fourth quarter of 2019, Sanofi
generated net sales of €9,608 million, an increase of 6.8%
(up 4.7% at CER). Full-year 2019 sales were €36,126 million, up
4.8% on a reported basis (up 2.8% at CER).
Fourth-quarter other
revenues increased 24.3% (up 20.4% at CER) to €409
million, reflecting the VaxServe sales contribution of non-Sanofi
products (€358 million, up 32.4% at CER). Full-year 2019 other
revenues increased 24.0% (up 18.0% at CER) to €1,505 million,
driven by the VaxServe sales contribution of non-Sanofi products
(€1,273 million, up 26.3% at CER) and the consolidation of
collaboration revenues from Swedish Orphan Biovitrum AB
(SOBI).
Fourth-quarter Gross
Profit increased 6.0% to €6,562 million (up 3.8% at CER).
The gross margin ratio decreased 0.5 percentage points to 68.3%
(68.2% at CER) versus the fourth quarter of 2018. The negative
impact from net price adjustments of inventory in the channel in
China, products and geographical mix in CHC, U.S. Diabetes net
price evolution and Vaccines more than offset the favorable impact
from Dupixent® growth. In the fourth quarter of 2019, the gross
margin ratio of segments were 72.8% for Pharmaceuticals (up 0.7
percentage points), 64.5% for CHC (down 1.5 percentage points) and
60.1% for Vaccines (down 0.3 percentage points). Full-year 2019
Gross Profit increased 5.3% to €25,657 million (up 3.1% at CER). In
2019, the gross margin ratio increased 0.3 percentage points to
71.0% (70.8% at CER) versus 2018.
Research and
Development (R&D) expenses increased 0.5% to €1,687
million in the fourth quarter of 2019. At CER, R&D expenses
decreased 0.7% reflecting smart spending initiatives as well as
portfolio prioritization. In the fourth quarter, the ratio of
R&D to sales decreased 1.1 percentage points to 17.6% compared
to the fourth quarter of 2018. In 2019, R&D expenses increased
2.2% to €6,022 million (up 0.2% at CER). In 2019, the ratio of
R&D to sales was 0.4 percentage points lower at 16.7% compared
to 2018.
Fourth-quarter selling general
and administrative expenses (SG&A) increased 0.1% to
€2,724 million. At CER, SG&A expenses were down 1.4%,
reflecting a decrease in general expenses which more than offset
increased investments in Specialty Care and Vaccines. In the fourth
quarter, the ratio of SG&A to sales decreased 1.8 percentage
points to 28.4% compared to the fourth quarter of 2018. In 2019,
SG&A expenses increased 0.5% to €9,880 million (down 1.4% at
CER). In 2019, the ratio of SG&A to sales was 1.2 percentage
points lower at 27.3% compared to 2018.
Fourth-quarter operating
expenses were €4,411 million, an increase of 0.3% and a
decrease of 1.2% at CER. Full-year 2019 operating expenses were
€15,902 million, an increase of 1.1% and down 0.8% at
CER.
Fourth-quarter other current
operating income net of expenses was -€70 million versus
-€148 million in the fourth quarter of 2018. In the fourth quarter
of 2019, this line included an expense of €241 million (versus an
expense of €65 million in the fourth quarter of 2018) corresponding
to the share of profit to Regeneron of the monoclonal antibodies
Alliance, reimbursement of development costs by Regeneron and the
reimbursement of commercialization-related expenses incurred by
Regeneron. In the fourth quarter of 2019, this line also included a
one-time income due to a legislation change related to
supplementary pension plans in France. In the fourth quarter of
2018, the “other current operating income net of expenses” line
also included charges related to a legal contingency provision as
well as a capital gain on an associate company and other accruals,
which in aggregate represented a net charge of €72 million. In
2019, other current operating income net of expenses was -€382
million versus -€64 million in 2018. The full-year 2019 expense
associated with the monoclonal antibodies Alliance with Regeneron
was €681 million, which compared with an expense of €211 million in
2018 (see appendix 7 for further details).
The share of profit from associates was
€119 million in the fourth quarter versus €121 million in 2018,
mainly reflecting the share of profit in Regeneron. In 2019, the
share of profit from associates was broadly stable at €420 million
versus €423 million in 2018.
In the fourth quarter,
non-controlling interests were -€8 million versus -€22 million in
prior period, reflecting the end of non-controlling interests
related to the Alliance with Bristol-Myers Squibb on Plavix® and
Avapro®. In 2019, non-controlling interests were -€35 million
versus -€106 million for 2018.
(9) See Appendix 3 for 2019
fourth-quarter consolidated income statement; see Appendix 11 for
definitions of financial indicators, and Appendix 4 for
reconciliation of IFRS net income reported to business net
income.
Fourth-quarter business
operating income increased 26.0% to €2,192 million. At
CER, business operating income increased 20.9%. The ratio of
business operating income to net sales increased 3.5 percentage
points to 22.8% versus the fourth quarter of 2018. Over the period,
the business operating income ratio of segments were 28.7% for
Pharmaceuticals (up 1.6 percentage points), 27.3% for CHC (down 1.7
percentage points) and 37.6% for Vaccines (up 1.5 percentage
points). In 2019, business operating income was €9,758 million, up
9.8% (up 7.1% at CER). In 2019, the ratio of business operating
income to net sales increased 1.2 percentage points to
27.0%.
Net financial expenses
were -€63 million in the fourth quarter versus -€60 million in the
same period of 2018, reflecting lower cost of net debt. The fourth
quarter of 2018 included a gain of €22 million in the market value
of a financial investment. Full-year 2019 net financial
expenses were -€264 million versus -€271 million in
2018.
Fourth-quarter and full-year 2019
effective tax rate were 22.1% and 22.0%,
respectively. Sanofi expects its effective tax rate to be around
22% in 2020.
Fourth-quarter business net
income(9) increased 23.5% to €1,684 million and increased
18.4% at CER. The ratio of business net income to net sales
increased 2.3 percentage points to 17.5% versus the fourth quarter
of 2018. In 2019, business net income(9) increased 9.8% to €7,489
million and increased 7.0% at CER. The ratio of business net income
to net sales increased 0.9 percentage points to 20.7% versus
2018.
In the fourth quarter of 2019, business earnings per
share(9) (EPS) increased 21.8% to €1.34 on a reported
basis and 17.3% at CER. The average number of shares outstanding
was 1,253.1 million versus 1,245.6 million in the fourth quarter of
2018. In 2019, business earnings per share(9) was €5.99, up 9.5% on
a reported basis and up 6.8% at CER. The average number of shares
outstanding was 1,249.9 million in 2019 versus 1,247.1 million in
2018. |
Reconciliation of IFRS net
income reported to business net income (see Appendix
4)
In 2019, the IFRS net income was €2,806
million. The main items excluded from the business net income
were:
- An amortization charge of
€2,146 million related to fair value remeasurement on intangible
assets of acquired companies (primarily Genzyme: €727 million,
Bioverativ: €488 million, Boehringer Ingelheim CHC business: €240
million, Aventis: €197 million) and to acquired intangible assets
(licenses/products: €102 million). An amortization charge of €510
million related to fair value remeasurement on intangible assets of
acquired companies (primarily Genzyme: €177 million, Bioverativ:
€108 million, Boehringer Ingelheim CHC business: €56 million,
Aventis: €44 million) and to acquired intangible assets
(licenses/products: €22 million) was recorded in the fourth
quarter. These items have no cash impact on the
Company.
- An impairment of intangible assets of €3,604 million
mainly related to Eloctate® (€2,803 million due to revision of
sales projections), Zantac® (€352 million), sotagliflozin and
Lemtrada®. The fourth quarter included an impairment of intangible
assets of €1,581 million of which €1,194 million related to
Eloctate® and €169 million to Zantac®.
- Restructuring costs and similar items of €1,062 million
(of which €158 million in the fourth quarter) mainly related to
streamlining initiatives in Japan, Europe and the
U.S.
- An income of €238 million
mainly reflecting a decrease of Bayer contingent considerations
linked to Lemtrada® (an income of €214 million of which €74 million
in the fourth quarter), a contingent price adjustment on the
disposal of SP MSD (€192 million) and a fair value remeasurement on
the CVR price (a charge of €49 million of which €32 million in the
fourth quarter).
- A net income of €327
million (of which a charge of €67 million in the fourth quarter)
mainly related to litigation.
- A €1,866 million tax effect
arising from the items listed above, mainly comprising €1,409
million of deferred taxes generated by amortization and impairments
of intangible assets and €311 million associated with restructuring
costs and similar items. The fourth quarter tax effect was €587
million, including €503 million of deferred taxes generated by
amortization and impairments of intangible assets and €64 million
associated with restructuring costs and similar items (see Appendix
4).
(9) See Appendix 3 for 2019
fourth-quarter consolidated income statement; see Appendix 11 for
definitions of financial indicators, and Appendix 4 for
reconciliation of IFRS net income reported to business net
income.
- An expense of €165 million
net of tax (of which €71 million In the fourth quarter) related to
restructuring costs of associates and joint ventures and expenses
arising from the impact of acquisitions on associates and joint
ventures.
Capital
Allocation
In 2019, Free Cash Flow (see definition
on Appendix 11) increased 48.6% to €6,026 million, after net
changes in working capital (-€580 million), capital expenditures
(-€1,405 million) and other asset acquisitions1 (-€576
million) net of disposal proceeds1 (€490 million), and
payments related to restructuring and similar items (-€1,142
million). Over the period, the dividend paid by Sanofi was €3,834
million and proceeds from disposals2 were €672 million. As a
consequence, net debt decreased from €17,628 million at December
31, 2018, to €15,107 million at December 31, 2019 (amount net of
€9,427 million cash and cash equivalents).1Not
exceeding €500 million per
transaction. 2Amount of the transaction above
€500 million per transaction.
---------------------------
Financial statements are not audited. The
audit procedures by the Statutory Auditors are
underway.
---------------------------
Forward-Looking
Statements
This press release contains
forward-looking statements as defined in the Private Securities
Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These
statements include projections and estimates and their underlying
assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future financial results, events,
operations, services, product development and potential, and
statements regarding future performance. Forward-looking statements
are generally identified by the words “expects”, “anticipates”,
“believes”, “intends”, “estimates”, “plans” and similar
expressions. Although Sanofi’s management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMA,
regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
Sanofi’s ability to benefit from external growth opportunities, to
complete related transactions and/or obtain regulatory clearances,
risks associated with intellectual property and any related pending
or future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest
rates, volatile economic conditions, the impact of cost containment
initiatives and subsequent changes thereto, the average number of
shares outstanding as well as those discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under “Risk Factors” and “Cautionary Statement
Regarding Forward-Looking Statements” in Sanofi’s annual report on
Form 20-F for the year ended December 31, 2018. Other than as
required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
Appendices
List of appendices
Appendix 1: |
2019 fourth-quarter
and full-year 2019 net sales by GBU, franchise, geographic region
and product |
Appendix 2: |
2019 fourth-quarter and full-year 2019 business net income
statement |
Appendix 3: |
2019 fourth-quarter
and full-year 2019 consolidated income statement |
Appendix 4: |
Reconciliation of
IFRS net income reported to business net income |
Appendix 5: Appendix 6: Appendix 7: Appendix 8 Appendix 9:
Appendix 10: |
Change in net debt Simplified consolidated balance sheet Currency
sensitivity Other current operating income net of expenses –
Regeneron Alliances R&D pipeline Expected R&D
milestones |
Appendix 11: |
Definitions of
non-GAAP financial indicators |
Appendix 1: 2019 fourth-quarter net sales by
GBU, franchise, geographic region and product
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q4 2019 (€ million) |
Total GBUs |
% CER |
% reported |
|
Europe |
% CER |
|
United States |
% CER |
|
Rest of the World |
% CER |
|
Emerging Markets |
% CER |
|
Total Franchises |
% CER |
% reported |
|
Aubagio |
465 |
3.9% |
6.7% |
|
106 |
-1.9% |
|
343 |
7.1% |
|
16 |
-17.6% |
|
17 |
70.0% |
|
482 |
5.4% |
8.1% |
|
Lemtrada |
52 |
-42.5% |
-40.2% |
|
16 |
-56.8% |
|
34 |
-28.9% |
|
2 |
-60.0% |
|
6 |
-33.3% |
|
58 |
-41.7% |
-39.6% |
|
Total MS |
517 |
-3.8% |
-1.1% |
|
122 |
-15.9% |
|
377 |
2.5% |
|
18 |
-27.3% |
|
23 |
21.1% |
|
540 |
-3.0% |
-0.4% |
|
Cerezyme |
121 |
-6.3% |
-4.7% |
|
63 |
-13.9% |
|
50 |
2.1% |
|
8 |
12.5% |
|
56 |
-7.9% |
|
177 |
-6.8% |
-6.8% |
|
Cerdelga |
54 |
23.3% |
25.6% |
|
20 |
18.8% |
|
31 |
19.2% |
|
3 |
200.0% |
|
1 |
0.0% |
|
55 |
22.7% |
25.0% |
|
Myozyme |
197 |
2.1% |
3.7% |
|
96 |
-1.0% |
|
88 |
7.6% |
|
13 |
-6.7% |
|
41 |
16.7% |
|
238 |
4.4% |
5.3% |
|
Fabrazyme |
186 |
0.6% |
3.3% |
|
48 |
6.7% |
|
106 |
-1.0% |
|
32 |
-3.2% |
|
29 |
15.4% |
|
215 |
2.4% |
4.4% |
|
Aldurazyme |
40 |
2.6% |
2.6% |
|
20 |
-5.0% |
|
13 |
8.3% |
|
7 |
14.3% |
|
14 |
-6.7% |
|
54 |
0.0% |
0.0% |
|
Total Rare Disease |
661 |
0.8% |
2.6% |
|
263 |
0.0% |
|
309 |
2.7% |
|
89 |
-3.3% |
|
154 |
5.3% |
|
815 |
1.6% |
2.6% |
|
Jevtana |
123 |
10.1% |
12.8% |
|
41 |
2.4% |
|
61 |
16.0% |
|
21 |
11.1% |
|
5 |
0.0% |
|
128 |
9.6% |
12.3% |
|
Mozobil |
52 |
11.4% |
18.2% |
|
13 |
8.3% |
|
33 |
26.9% |
|
6 |
-50.0% |
|
3 |
33.3% |
|
55 |
12.8% |
17.0% |
|
Thymoglobulin |
69 |
15.3% |
16.9% |
|
9 |
11.1% |
|
54 |
20.9% |
|
6 |
-14.3% |
|
20 |
5.3% |
|
89 |
12.8% |
14.1% |
|
Taxotere |
7 |
33.3% |
16.7% |
|
1 |
0.0% |
|
0 |
-100.0% |
|
6 |
16.7% |
|
35 |
6.3% |
|
42 |
10.5% |
10.5% |
|
Eloxatine |
5 |
-37.5% |
-37.5% |
|
1 |
- |
|
-2 |
- |
|
6 |
-25.0% |
|
37 |
2.9% |
|
42 |
-4.7% |
-2.3% |
|
Total Oncology |
333 |
12.6% |
16.4% |
|
102 |
15.7% |
|
174 |
18.4% |
|
57 |
-7.1% |
|
108 |
7.9% |
|
441 |
11.4% |
14.0% |
|
Dupixent |
668 |
133.1% |
140.3% |
|
64 |
117.2% |
|
545 |
134.7% |
|
59 |
137.5% |
|
11 |
450.0% |
|
679 |
135.4% |
142.5% |
|
Kevzara |
53 |
64.5% |
71.0% |
|
13 |
116.7% |
|
34 |
39.1% |
|
6 |
200.0% |
|
1 |
- |
|
54 |
67.7% |
74.2% |
|
Total immunology |
721 |
126.2% |
133.3% |
|
77 |
117.1% |
|
579 |
125.8% |
|
65 |
142.3% |
|
12 |
500.0% |
|
733 |
128.6% |
135.7% |
|
Alprolix |
107 |
8.4% |
12.6% |
|
0 |
- |
|
77 |
-1.3% |
|
30 |
47.4% |
|
1 |
- |
|
108 |
9.5% |
13.7% |
|
Eloctate |
170 |
-14.9% |
-12.4% |
|
0 |
- |
|
123 |
-25.6% |
|
47 |
35.3% |
|
7 |
200.0% |
|
177 |
-12.8% |
-9.7% |
|
Cablivi |
16 |
466.7% |
433.3% |
|
7 |
133.3% |
|
10 |
- |
|
-1 |
- |
|
0 |
- |
|
16 |
466.7% |
433.3% |
|
Total Rare Blood Disorder |
293 |
-2.4% |
0.3% |
|
7 |
133.3% |
|
210 |
-13.6% |
|
76 |
39.6% |
|
8 |
250.0% |
|
301 |
-0.7% |
2.4% |
|
Sanofi Genzyme (Specialty Care) |
2,525 |
19.7% |
22.9% |
|
571 |
6.7% |
|
1,649 |
25.4% |
|
305 |
18.2% |
|
305 |
12.8% |
|
2,830 |
18.9% |
21.6% |
|
Lantus |
485 |
-23.9% |
-22.3% |
|
146 |
-13.1% |
|
286 |
-26.9% |
|
53 |
-32.5% |
|
244 |
0.0% |
|
729 |
-17.2% |
-15.8% |
|
Toujeo |
186 |
1.7% |
3.3% |
|
87 |
14.3% |
|
77 |
-7.4% |
|
22 |
-9.1% |
|
48 |
48.4% |
|
234 |
8.5% |
10.9% |
|
Apidra |
54 |
-13.3% |
-10.0% |
|
32 |
-5.9% |
|
10 |
-47.1% |
|
12 |
22.2% |
|
34 |
20.7% |
|
88 |
-2.2% |
-1.1% |
|
Amaryl |
9 |
-18.2% |
-18.2% |
|
4 |
0.0% |
|
1 |
0.0% |
|
4 |
-33.3% |
|
70 |
3.0% |
|
79 |
0.0% |
2.6% |
|
Admelog |
56 |
-1.8% |
-1.8% |
|
4 |
100.0% |
|
52 |
-7.4% |
|
0 |
100.0% |
|
0 |
- |
|
56 |
-1.8% |
-1.8% |
|
Total Diabetes |
861 |
-15.5% |
-13.8% |
|
305 |
-4.4% |
|
454 |
-20.5% |
|
102 |
-21.8% |
|
407 |
7.4% |
|
1,268 |
-9.2% |
-7.8% |
|
Praluent |
68 |
-14.1% |
-12.8% |
|
24 |
4.3% |
|
39 |
-26.9% |
|
5 |
66.7% |
|
7 |
50.0% |
|
75 |
-11.0% |
-8.5% |
|
Multaq |
97 |
1.1% |
4.3% |
|
10 |
0.0% |
|
86 |
1.2% |
|
1 |
0.0% |
|
2 |
0.0% |
|
99 |
1.1% |
4.2% |
|
Total Cardiovascular |
165 |
-5.8% |
-3.5% |
|
34 |
3.0% |
|
125 |
-9.7% |
|
6 |
50.0% |
|
9 |
33.3% |
|
174 |
-4.5% |
-1.7% |
|
Plavix |
83 |
-8.9% |
-7.8% |
|
34 |
-5.4% |
|
0 |
- |
|
49 |
-11.3% |
|
129 |
-47.5% |
|
212 |
-36.9% |
-35.4% |
|
Lovenox |
197 |
-14.4% |
-14.0% |
|
170 |
-14.6% |
|
7 |
-22.2% |
|
20 |
-9.5% |
|
138 |
16.2% |
|
335 |
-4.0% |
-3.2% |
|
Renagel / Renvela |
56 |
-29.1% |
-29.1% |
|
12 |
-14.3% |
|
35 |
-40.4% |
|
9 |
25.0% |
|
26 |
47.1% |
|
82 |
-15.6% |
-14.6% |
|
Aprovel |
45 |
10.3% |
15.4% |
|
31 |
14.8% |
|
6 |
100.0% |
|
8 |
-33.3% |
|
86 |
-24.1% |
|
131 |
-15.2% |
-13.2% |
|
Synvisc / Synvisc one |
65 |
0.0% |
0.0% |
|
6 |
-14.3% |
|
58 |
1.8% |
|
1 |
0.0% |
|
16 |
-6.3% |
|
81 |
-1.2% |
0.0% |
|
Allegra |
28 |
0.0% |
7.7% |
|
2 |
100.0% |
|
0 |
- |
|
26 |
-4.0% |
|
0 |
- |
|
28 |
0.0% |
7.7% |
|
Stilnox |
40 |
-11.4% |
-9.1% |
|
10 |
-9.1% |
|
12 |
0.0% |
|
18 |
-19.0% |
|
16 |
6.7% |
|
56 |
-6.8% |
-5.1% |
|
Depakine |
45 |
2.3% |
2.3% |
|
42 |
7.7% |
|
0 |
- |
|
3 |
-40.0% |
|
78 |
16.9% |
|
123 |
11.0% |
12.8% |
|
Tritace |
36 |
2.8% |
0.0% |
|
35 |
0.0% |
|
0 |
- |
|
1 |
100.0% |
|
20 |
5.6% |
|
56 |
3.7% |
3.7% |
|
Generics |
99 |
-1.0% |
2.1% |
|
40 |
25.0% |
|
37 |
-20.0% |
|
22 |
0.0% |
|
172 |
0.0% |
|
271 |
-0.4% |
0.4% |
|
Other other Rx |
605 |
1.9% |
2.5% |
|
452 |
0.7% |
|
53 |
8.2% |
|
100 |
4.3% |
|
296 |
1.0% |
|
901 |
1.6% |
2.9% |
|
Total Established Rx Products |
1,299 |
-4.0% |
-3.0% |
|
834 |
-1.9% |
|
208 |
-11.3% |
|
257 |
-4.2% |
|
977 |
-9.3% |
|
2,276 |
-6.3% |
-5.0% |
|
Primary Care |
2,325 |
-8.7% |
-7.3% |
|
1,173 |
-2.4% |
|
787 |
-16.6% |
|
365 |
-9.3% |
|
1,393 |
-4.7% |
|
3,718 |
-7.2% |
-5.8% |
|
China and Emerging Markets |
1,698 |
-1.9% |
-0.9% |
|
|
|
|
|
|
|
|
|
|
1,698 |
-1.9% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Pharmaceuticals |
6,548 |
2.4% |
4.3% |
|
1,744 |
0.4% |
|
2,436 |
7.8% |
|
670 |
1.4% |
|
1,698 |
-1.9% |
|
6,548 |
2.4% |
4.3% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergy, Cough and Cold |
281 |
1.9% |
4.9% |
|
77 |
-15.4% |
|
64 |
1.6% |
|
39 |
24.1% |
|
101 |
12.8% |
|
281 |
1.9% |
4.9% |
|
Pain |
329 |
-2.4% |
-2.1% |
|
133 |
-9.5% |
|
47 |
0.0% |
|
35 |
3.0% |
|
114 |
4.5% |
|
329 |
-2.4% |
-2.1% |
|
Digestive |
227 |
-13.3% |
-11.3% |
|
72 |
-11.0% |
|
21 |
-60.4% |
|
9 |
-33.3% |
|
125 |
10.1% |
|
227 |
-13.3% |
-11.3% |
|
Nutritional |
165 |
-7.5% |
-5.2% |
|
31 |
-6.1% |
|
9 |
-10.0% |
|
64 |
0.0% |
|
61 |
-14.5% |
|
165 |
-7.5% |
-5.2% |
|
Consumer Healthcare |
1,152 |
-5.2% |
-3.5% |
|
325 |
-11.7% |
|
246 |
-12.8% |
|
156 |
2.7% |
|
425 |
3.0% |
|
1,152 |
-5.2% |
-3.5% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Polio / Pertussis / Hib |
443 |
-13.7% |
-12.1% |
|
75 |
-9.6% |
|
110 |
3.9% |
|
15 |
-56.3% |
|
243 |
-16.4% |
|
443 |
-13.7% |
-12.1% |
|
Adult Booster Vaccines |
147 |
6.7% |
8.9% |
|
39 |
18.2% |
|
74 |
-5.3% |
|
7 |
-25.0% |
|
27 |
50.0% |
|
147 |
6.7% |
8.9% |
|
Meningitis/Pneumonia |
124 |
-6.1% |
-5.3% |
|
0 |
- |
|
57 |
-31.3% |
|
2 |
-40.0% |
|
65 |
41.3% |
|
124 |
-6.1% |
-5.3% |
|
Influenza Vaccines |
1,039 |
69.1% |
74.3% |
|
130 |
40.9% |
|
705 |
65.7% |
|
41 |
46.2% |
|
163 |
139.4% |
|
1,039 |
69.1% |
74.3% |
|
Travel And Other Endemic Vaccines |
123 |
-7.7% |
-5.4% |
|
29 |
7.4% |
|
28 |
-15.2% |
|
15 |
-20.0% |
|
51 |
-7.3% |
|
123 |
-7.7% |
-5.4% |
|
Vaccines |
1,908 |
22.0% |
25.0% |
|
275 |
15.1% |
|
1,002 |
33.1% |
|
79 |
-9.2% |
|
552 |
14.2% |
|
1,908 |
22.0% |
25.0% |
|
Total Company |
9,608 |
4.7% |
6.8% |
|
2,344 |
0.0% |
|
3,684 |
11.8% |
|
905 |
0.6% |
|
2,675 |
1.8% |
|
9,608 |
4.7% |
6.8% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2019 Full-year 2019 net sales by GBU, franchise,
geographic region and product
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2019 (€ million) |
Total GBUs |
% CER |
% reported |
|
Europe |
% CER |
|
United States |
% CER |
|
Rest of the World |
% CER |
|
Emerging Markets |
% CER |
|
Total Franchises |
% CER |
% reported |
|
Aubagio |
1,824 |
9.6% |
14.1% |
|
412 |
7.0% |
|
1,351 |
10.8% |
|
61 |
3.5% |
|
55 |
20.8% |
|
1,879 |
10.0% |
14.1% |
|
Lemtrada |
256 |
-34.1% |
-31.7% |
|
94 |
-43.7% |
|
151 |
-24.3% |
|
11 |
-47.4% |
|
25 |
3.7% |
|
281 |
-31.6% |
-30.1% |
|
Total MS |
2,080 |
1.3% |
5.4% |
|
506 |
-8.3% |
|
1,502 |
5.9% |
|
72 |
-9.2% |
|
80 |
14.7% |
|
2,160 |
1.8% |
5.4% |
|
Cerezyme |
463 |
-5.8% |
-3.7% |
|
246 |
-8.9% |
|
184 |
0.6% |
|
33 |
-13.5% |
|
245 |
20.4% |
|
708 |
2.7% |
-0.4% |
|
Cerdelga |
201 |
25.0% |
28.8% |
|
73 |
43.1% |
|
118 |
14.3% |
|
10 |
42.9% |
|
5 |
100.0% |
|
206 |
26.4% |
29.6% |
|
Myozyme |
772 |
5.2% |
7.8% |
|
382 |
1.9% |
|
331 |
10.6% |
|
59 |
0.0% |
|
146 |
26.6% |
|
918 |
8.3% |
9.3% |
|
Fabrazyme |
715 |
2.4% |
6.2% |
|
184 |
5.1% |
|
410 |
1.6% |
|
121 |
0.9% |
|
98 |
29.3% |
|
813 |
5.3% |
7.7% |
|
Aldurazyme |
154 |
4.9% |
6.9% |
|
78 |
1.3% |
|
51 |
11.4% |
|
25 |
4.2% |
|
70 |
19.4% |
|
224 |
9.2% |
8.7% |
|
Total Rare Disease |
2,551 |
2.6% |
5.6% |
|
1,027 |
1.9% |
|
1,183 |
4.7% |
|
341 |
-2.1% |
|
614 |
24.0% |
|
3,165 |
6.5% |
7.0% |
|
Jevtana |
458 |
11.0% |
14.8% |
|
168 |
7.0% |
|
212 |
12.3% |
|
78 |
17.7% |
|
26 |
13.0% |
|
484 |
11.1% |
14.7% |
|
Mozobil |
184 |
9.3% |
14.3% |
|
49 |
4.3% |
|
115 |
14.6% |
|
20 |
-5.6% |
|
14 |
50.0% |
|
198 |
11.7% |
15.8% |
|
Thymoglobulin |
258 |
11.7% |
16.2% |
|
36 |
0.0% |
|
198 |
16.0% |
|
24 |
0.0% |
|
96 |
30.7% |
|
354 |
16.5% |
19.2% |
|
Taxotere |
29 |
-6.3% |
-9.4% |
|
4 |
33.3% |
|
-1 |
-200.0% |
|
26 |
-3.6% |
|
144 |
5.2% |
|
173 |
3.0% |
4.2% |
|
Eloxatine |
22 |
-31.3% |
-31.3% |
|
2 |
0.0% |
|
-6 |
- |
|
26 |
-13.3% |
|
181 |
19.3% |
|
203 |
10.4% |
11.5% |
|
Total Oncology |
1,205 |
8.3% |
12.1% |
|
374 |
6.8% |
|
613 |
11.3% |
|
218 |
3.0% |
|
490 |
16.7% |
|
1,695 |
10.6% |
13.5% |
|
Dupixent |
2,045 |
149.7% |
161.2% |
|
200 |
165.3% |
|
1,669 |
140.8% |
|
176 |
247.9% |
|
29 |
460.0% |
|
2,074 |
151.6% |
163.2% |
|
Kevzara |
183 |
112.0% |
120.5% |
|
43 |
207.1% |
|
115 |
70.3% |
|
25 |
380.0% |
|
2 |
- |
|
185 |
114.5% |
122.9% |
|
Total immunology |
2,228 |
146.1% |
157.3% |
|
243 |
171.9% |
|
1,784 |
134.5% |
|
201 |
260.4% |
|
31 |
500.0% |
|
2,259 |
148.1% |
159.4% |
|
Alprolix |
411 |
36.8% |
44.2% |
|
0 |
- |
|
300 |
27.9% |
|
111 |
68.3% |
|
1 |
- |
|
412 |
37.2% |
44.6% |
|
Eloctate |
664 |
3.8% |
9.6% |
|
0 |
- |
|
517 |
-2.0% |
|
147 |
31.1% |
|
20 |
850.0% |
|
684 |
6.6% |
12.5% |
|
Cablivi |
56 |
- |
- |
|
22 |
450.0% |
|
34 |
- |
|
0 |
- |
|
0 |
- |
|
56 |
- |
- |
|
Total Rare Blood Disorder |
1,131 |
20.0% |
26.4% |
|
22 |
450.0% |
|
851 |
11.8% |
|
258 |
45.0% |
|
21 |
900.0% |
|
1,152 |
22.0% |
28.4% |
|
Sanofi Genzyme (Specialty Care) |
9,195 |
22.4% |
27.2% |
|
2,172 |
8.4% |
|
5,933 |
28.4% |
|
1,090 |
24.7% |
|
1,236 |
24.4% |
|
10,431 |
22.7% |
26.1% |
|
Lantus |
1,951 |
-27.1% |
-24.6% |
|
584 |
-14.6% |
|
1,149 |
-32.5% |
|
218 |
-26.6% |
|
1,061 |
9.7% |
|
3,012 |
-17.0% |
-15.5% |
|
Toujeo |
703 |
-3.4% |
-1.0% |
|
334 |
15.5% |
|
289 |
-20.3% |
|
80 |
1.3% |
|
180 |
39.2% |
|
883 |
3.2% |
5.1% |
|
Apidra |
214 |
-15.3% |
-13.7% |
|
129 |
-5.1% |
|
46 |
-41.9% |
|
39 |
0.0% |
|
130 |
22.9% |
|
344 |
-3.6% |
-3.6% |
|
Amaryl |
41 |
-14.9% |
-12.8% |
|
15 |
-11.8% |
|
2 |
0.0% |
|
24 |
-17.9% |
|
293 |
0.0% |
|
334 |
-2.1% |
-0.3% |
|
Admelog |
250 |
155.9% |
168.8% |
|
15 |
114.3% |
|
235 |
158.1% |
|
0 |
- |
|
0 |
- |
|
250 |
155.9% |
168.8% |
|
Total Diabetes |
3,412 |
-15.6% |
-12.9% |
|
1,208 |
-5.0% |
|
1,811 |
-21.5% |
|
393 |
-17.1% |
|
1,701 |
10.3% |
|
5,113 |
-8.2% |
-6.6% |
|
Praluent |
237 |
-7.6% |
-5.2% |
|
107 |
24.4% |
|
112 |
-30.5% |
|
18 |
70.0% |
|
21 |
81.8% |
|
258 |
-3.8% |
-1.1% |
|
Multaq |
339 |
-5.5% |
-1.2% |
|
40 |
-7.0% |
|
295 |
-5.4% |
|
4 |
0.0% |
|
8 |
14.3% |
|
347 |
-5.1% |
-0.9% |
|
Total Cardiovascular |
576 |
-6.4% |
-2.9% |
|
147 |
14.0% |
|
407 |
-14.0% |
|
22 |
50.0% |
|
29 |
55.6% |
|
605 |
-4.6% |
-1.0% |
|
Plavix |
338 |
-9.3% |
-7.4% |
|
139 |
-4.8% |
|
0 |
- |
|
199 |
-12.4% |
|
996 |
-8.6% |
|
1,334 |
-8.8% |
-7.4% |
|
Lovenox |
817 |
-17.6% |
-17.4% |
|
709 |
-18.4% |
|
33 |
-18.4% |
|
75 |
-8.6% |
|
542 |
13.7% |
|
1,359 |
-7.4% |
-7.2% |
|
Renagel / Renvela |
216 |
-39.2% |
-37.2% |
|
51 |
-15.0% |
|
133 |
-50.2% |
|
32 |
3.2% |
|
95 |
38.8% |
|
311 |
-26.5% |
-24.3% |
|
Aprovel |
204 |
7.5% |
9.1% |
|
113 |
4.6% |
|
26 |
150.0% |
|
65 |
-8.7% |
|
470 |
-0.2% |
|
674 |
2.0% |
3.4% |
|
Synvisc / Synvisc one |
248 |
-6.7% |
-2.7% |
|
25 |
0.0% |
|
211 |
-7.8% |
|
12 |
0.0% |
|
61 |
1.7% |
|
309 |
-5.1% |
-1.3% |
|
Allegra |
128 |
-2.4% |
3.2% |
|
10 |
25.0% |
|
0 |
- |
|
118 |
-4.3% |
|
0 |
- |
|
128 |
-2.4% |
3.2% |
|
Stilnox |
157 |
-11.2% |
-7.6% |
|
37 |
-5.1% |
|
42 |
-11.1% |
|
78 |
-14.0% |
|
62 |
1.6% |
|
219 |
-7.8% |
-5.2% |
|
Depakine |
176 |
-0.6% |
-0.6% |
|
163 |
0.0% |
|
0 |
- |
|
13 |
-7.1% |
|
300 |
7.6% |
|
476 |
4.4% |
5.3% |
|
Tritace |
145 |
-0.7% |
-1.4% |
|
141 |
-0.7% |
|
0 |
- |
|
4 |
0.0% |
|
73 |
-1.4% |
|
218 |
-0.9% |
-1.4% |
|
Generics |
405 |
-51.6% |
-49.7% |
|
130 |
-77.1% |
|
152 |
16.9% |
|
123 |
1.8% |
|
670 |
0.0% |
|
1,075 |
-27.9% |
-27.9% |
|
Other other Rx |
2,254 |
-4.4% |
-3.3% |
|
1,679 |
-4.9% |
|
189 |
-4.3% |
|
386 |
-1.9% |
|
1,202 |
0.7% |
|
3,456 |
-2.7% |
-2.2% |
|
Total Established Rx Products |
5,088 |
-15.0% |
-13.7% |
|
3,197 |
-17.9% |
|
786 |
-14.6% |
|
1,105 |
-5.5% |
|
4,471 |
0.6% |
|
9,559 |
-8.3% |
-7.5% |
|
Primary Care |
9,076 |
-14.8% |
-12.8% |
|
4,552 |
-14.0% |
|
3,004 |
-18.8% |
|
1,520 |
-8.4% |
|
6,201 |
3.3% |
|
15,277 |
-8.2% |
-6.9% |
|
China and Emerging Markets |
7,437 |
6.4% |
5.4% |
|
|
|
|
|
|
|
|
|
|
7,437 |
6.4% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Pharmaceuticals |
25,708 |
2.2% |
4.1% |
|
6,724 |
-7.9% |
|
8,937 |
7.4% |
|
2,610 |
3.0% |
|
7,437 |
6.4% |
|
25,708 |
2.2% |
4.1% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergy, Cough and Cold |
1,179 |
2.2% |
4.9% |
|
324 |
-6.3% |
|
323 |
0.7% |
|
160 |
13.3% |
|
372 |
8.0% |
|
1,179 |
2.2% |
4.9% |
|
Pain |
1,259 |
1.3% |
0.4% |
|
499 |
-4.0% |
|
185 |
6.1% |
|
134 |
7.6% |
|
441 |
4.0% |
|
1,259 |
1.3% |
0.4% |
|
Digestive |
1,004 |
0.0% |
1.8% |
|
307 |
-1.9% |
|
157 |
-24.1% |
|
51 |
-9.3% |
|
489 |
13.7% |
|
1,004 |
0.0% |
1.8% |
|
Nutritional |
657 |
-4.1% |
-2.7% |
|
121 |
-2.4% |
|
38 |
-2.7% |
|
257 |
-1.6% |
|
241 |
-7.8% |
|
657 |
-4.1% |
-2.7% |
|
Consumer Healthcare |
4,687 |
-0.8% |
0.6% |
|
1,311 |
-6.4% |
|
1,086 |
-3.6% |
|
638 |
2.7% |
|
1,652 |
4.7% |
|
4,687 |
-0.8% |
0.6% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Polio / Pertussis / Hib |
1,946 |
9.8% |
11.3% |
|
299 |
1.0% |
|
380 |
-9.6% |
|
159 |
-3.2% |
|
1,108 |
23.4% |
|
1,946 |
9.8% |
11.3% |
|
Adult Booster Vaccines |
563 |
16.2% |
19.8% |
|
166 |
28.7% |
|
320 |
11.7% |
|
28 |
0.0% |
|
49 |
16.7% |
|
563 |
16.2% |
19.8% |
|
Meningitis/Pneumonia |
682 |
8.4% |
12.0% |
|
0 |
- |
|
507 |
3.4% |
|
14 |
-12.5% |
|
161 |
29.1% |
|
682 |
8.4% |
12.0% |
|
Influenza Vaccines |
1,891 |
7.3% |
10.7% |
|
218 |
23.7% |
|
1,289 |
0.2% |
|
88 |
4.9% |
|
296 |
35.0% |
|
1,891 |
7.3% |
10.7% |
|
Travel And Other Endemic Vaccines |
539 |
8.4% |
10.5% |
|
129 |
10.3% |
|
143 |
1.5% |
|
61 |
7.1% |
|
206 |
12.7% |
|
539 |
8.4% |
10.5% |
|
Vaccines |
5,731 |
9.3% |
12.0% |
|
817 |
12.1% |
|
2,733 |
1.1% |
|
356 |
1.8% |
|
1,825 |
24.0% |
|
5,731 |
9.3% |
12.0% |
|
Total Company |
36,126 |
2.8% |
4.8% |
|
8,852 |
-6.1% |
|
12,756 |
5.0% |
|
3,604 |
2.8% |
|
10,914 |
8.7% |
|
36,126 |
2.8% |
4.8% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Appendix 2: Business net income
statement
Fourth Quarter
2019 |
Pharmaceuticals |
Consumer Healthcare |
Vaccines |
Others(1) |
Total Group |
€ million |
Q4 2019 |
Q4 2018 |
Change |
Q4 2019 |
Q4 2018 |
Change |
Q4 2019 |
Q4 2018 |
Change |
Q4 2019 |
Q4 2018 |
Change |
Q4 2019 |
Q4 2018 |
Change |
Net sales |
6,548 |
6,276 |
4.3% |
1,152 |
1,194 |
(3.5)% |
1,908 |
1,527 |
25.0% |
— |
— |
|
9,608 |
8,997 |
6.8% |
Other revenues |
51 |
67 |
(23.9)% |
— |
— |
|
358 |
262 |
36.6% |
— |
— |
|
409 |
329 |
24.3% |
Cost of Sales |
(1,830) |
(1,820) |
0.5% |
(409) |
(406) |
0.7% |
(1,119) |
(866) |
29.2% |
(97) |
(46) |
110.9% |
(3,455) |
(3,138) |
10.1% |
As % of net sales |
(27.9)% |
(29.0)% |
|
(35.5)% |
(34.0)% |
|
(58.6)% |
(56.7)% |
|
|
|
|
(36.0)% |
(34.9)% |
|
Gross Profit |
4,769 |
4,523 |
5.4% |
743 |
788 |
(5.7)% |
1,147 |
923 |
24.3% |
(97) |
(46) |
|
6,562 |
6,188 |
6.0% |
As % of net sales |
72.8% |
72.1% |
|
64.5% |
66.0% |
|
60.1% |
60.4% |
|
|
|
|
68.3% |
68.8% |
|
Research and development expenses |
(1,292) |
(1,311) |
(1.4)% |
(45) |
(48) |
(6.3)% |
(195) |
(162) |
20.4% |
(155) |
(157) |
(1.3)% |
(1,687) |
(1,678) |
0.5% |
As % of net sales |
(19.7)% |
(20.9)% |
|
(3.9)% |
(4.0)% |
|
(10.2)% |
(10.6)% |
|
|
|
|
(17.6)% |
(18.7)% |
|
Selling and general expenses |
(1,484) |
(1,485) |
(0.1)% |
(418) |
(409) |
2.2% |
(238) |
(210) |
13.3% |
(584) |
(617) |
(5.3)% |
(2,724) |
(2,721) |
0.1% |
As % of net sales |
(22.7)% |
(23.7)% |
|
(36.3)% |
(34.3)% |
|
(12.5)% |
(13.8)% |
|
|
|
|
(28.4)% |
(30.2)% |
|
Other current operating
income/expenses |
(245) |
(123) |
|
54 |
16 |
|
4 |
(1) |
|
117 |
(40) |
|
(70) |
(148) |
|
Share of profit/loss of associates* and
joint-ventures |
136 |
120 |
|
(17) |
— |
|
— |
1 |
|
— |
— |
|
119 |
121 |
|
Net income attributable to
non-controlling interests |
(5) |
(21) |
|
(3) |
(1) |
|
— |
— |
|
— |
— |
|
(8) |
(22) |
|
Business operating
income |
1,879 |
1,703 |
10.3% |
314 |
346 |
(9.2)% |
718 |
551 |
30.3% |
(719) |
(860) |
(16.4)% |
2,192 |
1,740 |
26.0% |
As % of net sales |
28.7% |
27.1% |
|
27.3% |
29.0% |
|
37.6% |
36.1% |
|
|
|
|
22.8% |
19.3% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income and
expenses |
(63) |
(60) |
|
|
|
|
|
|
|
|
Income tax expenses |
|
(445) |
(316) |
|
|
|
|
|
|
|
|
Tax rate** |
|
22.1% |
20.0% |
|
|
|
|
|
|
|
|
Business net
income |
|
1,684 |
1,364 |
23.5% |
|
|
|
|
|
|
|
As % of net
sales |
|
17.5% |
15.2% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Business earnings /
share (in euros)*** |
1.34 |
1.10 |
21.8% |
*** Net of tax.*** Determined on the
basis of Business income before tax, associates, and
non-controlling interests.*** Based on an average
number of shares outstanding of 1,253.1 million in the fourth
quarter of 2019 and 1,245.6 million in the fourth quarter of
2018.(1) Other includes the cost of Global Support
Functions (Medical Affairs, External Affairs, Finance, Human
Resources, Information Solution & Technologies, Sanofi Business
Services, etc…).
2019 |
Pharmaceuticals |
Consumer Healthcare |
Vaccines |
Others (1) |
Total Group |
€ million |
2019 |
2018 |
Change |
2019 |
2018 |
Change |
2019 |
2018 |
Change |
2019 |
2018 |
Change |
2019 |
2018 |
Change |
Net sales |
25,708 |
24,685 |
4.1% |
4,687 |
4,660 |
0.6% |
5,731 |
5,118 |
12.0% |
— |
— |
|
36,126 |
34,463 |
4.8% |
Other revenues |
229 |
252 |
(9.1)% |
1 |
— |
|
1,275 |
962 |
32.5% |
— |
— |
|
1,505 |
1,214 |
24.0% |
Cost of Sales |
(6,745) |
(6,738) |
0.1% |
(1,582) |
(1,539) |
2.8% |
(3,380) |
(2,854) |
18.4% |
(267) |
(190) |
40.5% |
(11,974) |
(11,321) |
5.8% |
As % of net sales |
(26.2)% |
(27.3)% |
|
(33.8)% |
(33.0)% |
|
(59.0)% |
(55.8)% |
|
|
|
|
(33.1)% |
(32.8)% |
|
Gross Profit |
19,192 |
18,199 |
5.5% |
3,106 |
3,121 |
(0.5)% |
3,626 |
3,226 |
12.4% |
(267) |
(190) |
|
25,657 |
24,356 |
5.3% |
As % of net sales |
74.7% |
73.7% |
|
66.3% |
67.0% |
|
63.3% |
63.0% |
|
|
|
|
71.0% |
70.7% |
|
Research and development expenses |
(4,622) |
(4,572) |
1.1% |
(148) |
(143) |
3.5% |
(653) |
(555) |
17.7% |
(599) |
(624) |
(4.0)% |
(6,022) |
(5,894) |
2.2% |
As % of net sales |
(18.0)% |
(18.5)% |
|
(3.2)% |
(3.1)% |
|
(11.4)% |
(10.8)% |
|
|
|
|
(16.7)% |
(17.1)% |
|
Selling and general expenses |
(5,375) |
(5,431) |
(1.0)% |
(1,563) |
(1,534) |
1.9% |
(786) |
(710) |
10.7% |
(2,156) |
(2,156) |
— |
(9,880) |
(9,831) |
0.5% |
As % of net sales |
(20.9)% |
(22.0)% |
|
(33.3)% |
(32.9)% |
|
(13.7)% |
(13.9)% |
|
|
|
|
(27.3)% |
(28.5)% |
|
Other current operating
income/expenses |
(633) |
(37) |
|
192 |
101 |
|
(1) |
(4) |
|
60 |
(124) |
|
(382) |
(64) |
|
Share of profit/loss of associates* and
joint-ventures |
428 |
425 |
|
(17) |
1 |
|
9 |
(3) |
|
— |
— |
|
420 |
423 |
|
Net income attributable to non
controlling interests |
(21) |
(96) |
|
(14) |
(10) |
|
— |
— |
|
— |
— |
|
(35) |
(106) |
|
Business operating
income |
8,969 |
8,488 |
5.7% |
1,556 |
1,536 |
1.3% |
2,195 |
1,954 |
12.3% |
(2,962) |
(3,094) |
(4.3)% |
9,758 |
8,884 |
9.8% |
As % of net sales |
34.9% |
34.4% |
|
33.2% |
33.0% |
|
38.3% |
38.2% |
|
|
|
|
27.0% |
25.8% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income and
expenses |
(264) |
(271) |
|
|
|
|
|
|
|
|
Income tax expenses |
|
|
|
(2,005) |
(1,794) |
|
|
|
|
|
|
|
|
Tax rate** |
|
22.0% |
21.6% |
|
|
|
|
|
|
|
|
Business net
income |
|
7,489 |
6,819 |
9.8% |
|
|
|
|
|
|
|
As % of net
sales |
|
20.7% |
19.8% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Business earnings /
share (in euros)*** |
5.99 |
5.47 |
9.5% |
*** Net of tax.*** Determined on the
basis of Business income before tax, associates, and
non-controlling interests.*** Based on an average
number of shares outstanding of 1,249.9 million in 2019 and 1,247.1
million in 2018.(1) Other includes the cost of
Global Support Functions (Medical Affairs, External Affairs,
Finance, Human Resources, Information Solution & Technologies,
Sanofi Business Services, etc…).
Appendix 3: Consolidated income
statements
€ million |
Q4 2019 |
Q4 2018 |
2019 |
2018 |
Net sales |
9,608 |
8,997 |
36,126 |
34,463 |
Other revenues |
409 |
329 |
1,505 |
1,214 |
Cost of sales |
(3,457) |
(3,138) |
(11,976) |
(11,435) |
Gross profit |
6,560 |
6,188 |
25,655 |
24,242 |
Research and development expenses |
(1,686) |
(1,678) |
(6,018) |
(5,894) |
Selling and general expenses |
(2,737) |
(2,730) |
(9,883) |
(9,859) |
Other operating income |
429 |
83 |
825 |
484 |
Other operating expenses |
(499) |
(231) |
(1,207) |
(548) |
Amortization of intangible assets |
(510) |
(634) |
(2,146) |
(2,170) |
Impairment of intangible assets |
(1,581) |
(426) |
(3,604) |
(718) |
Fair value remeasurement of contingent consideration |
(4) |
— |
238 |
117 |
Restructuring costs and similar items |
(158) |
(765) |
(1,062) |
(1,480) |
Other gains and losses, and litigation (1) |
67 |
(7) |
327 |
502 |
Operating income |
(119) |
(200) |
3,125 |
4,676 |
Financial expenses |
(91) |
(103) |
(444) |
(435) |
Financial income |
18 |
43 |
141 |
164 |
Income
before tax and associates and joint ventures |
(192) |
(260) |
2,822 |
4,405 |
Income tax expense |
142 |
243 |
(139) |
(481) |
Share of profit/(loss) of associates and joint ventures |
48 |
301 |
255 |
499 |
Net income excluding the
exchanged/held-for-exchange Animal Health business |
(2) |
284 |
2,938 |
4,423 |
Net income/(loss) of the exchanged/held-for-exchange Animal Health
business |
(1) |
(9) |
(101) |
(13) |
Net income |
(3) |
275 |
2,837 |
4,410 |
Net income attributable to non-controlling interests |
7 |
21 |
31 |
104 |
Net income attributable to equity
holders of Sanofi |
(10) |
254 |
2,806 |
4,306 |
Average number of shares outstanding
(million) |
1,253.1 |
1,245.6 |
1,249.9 |
1,247.1 |
Earnings per share excluding the
exchanged/held-for-exchange Animal Health business (in
euros) |
(0.01) |
0.21 |
2.33 |
3.46 |
IFRS Earnings per share (in
euros) |
(0.01) |
0.20 |
2.24 |
3.45 |
(1) In 2019, mainly related to
litigation settlement. In 2018, separation costs for the European
Generics business divestiture.
Appendix 4: Reconciliation of Net income
attributable to equity holders of Sanofi to Business net
income
€ million |
Q4 2019 |
|
Q4 2018 |
|
Change |
Net income attributable to equity
holders of Sanofi |
(10) |
|
254 |
|
(103.9)% |
Amortization of intangible assets(1) |
510 |
|
634 |
|
|
Impairment of intangible assets(2) |
1,581 |
|
426 |
|
|
Fair value remeasurement of contingent
consideration |
4 |
|
— |
|
|
Other expenses related to business
combinations |
— |
|
9 |
|
|
Restructuring costs and similar items |
158 |
|
765 |
|
|
Other gains and losses, and litigation
(3) |
(67) |
|
7 |
|
|
Effects of IFRS 16 on Lease
contracts (4) |
24 |
|
— |
|
|
Tax effect of the items listed above
: |
(587) |
|
(503) |
|
|
Amortization and impairment of intangible assets |
(503) |
|
(241) |
|
|
Fair value remeasurement of contingent consideration |
(10) |
|
3 |
|
|
Other expenses related to business combinations |
— |
|
(2) |
|
|
Restructuring costs and similar items |
(62) |
|
(220) |
|
|
Other tax effects |
(12) |
|
(43) |
|
|
Other tax items(5) |
— |
|
(56) |
|
|
Share of items listed above attributable
to non-controlling interests |
(1) |
|
(1) |
|
|
Restructuring costs of associates and
joint ventures, and expenses arising from the impact of
acquisitions on associates and joint ventures |
71 |
|
(180) |
|
|
Animal Health items |
1 |
|
9 |
|
|
Business net income |
1,684 |
|
1,364 |
|
23.5% |
IFRS earnings per share (6) (in
euros) |
(0.01) |
|
0.20 |
|
|
- Of which related to amortization expense generated by
the remeasurement of intangible assets as part of business
combinations: €488 million in the fourth quarter of 2019 and
€520 million in the fourth quarter of 2018.
- In 2019, of which Eloctate impairment (€1,194 million)
and Zantac impairment (€169 million)
- In 2019, mainly related to litigation settlement. In
2018, separation costs for the European Generics business
divestiture.
- Impact of new lease standard IFRS 16, is effective
January 1, 2019 using the modified retrospective transition method
(no restatement of prior periods), since Business Net Income
remains reported as previously under IAS 17 and related
interpretations for comparison purposes.
- In 2018, mainly due to US tax reform.
- Based on an average number of shares outstanding of
1,253.1 million in the fourth quarter of 2019 and 1,245.6 million
in the fourth quarter of 2018.
€ million |
2019 |
|
2018 |
|
Change |
Net income attributable to
equity holders of Sanofi |
2,806 |
|
4,306 |
|
(34.8)% |
Amortization of intangible
assets(1) |
2,146 |
|
2,170 |
|
|
Impairment of intangible assets(2) |
3,604 |
|
718 |
|
|
Fair value remeasurement of contingent
consideration |
(238) |
|
(117) |
|
|
Expenses arising from the impact of
acquisitions on inventories |
3 |
|
114 |
|
|
Other expenses related to business
combinations |
— |
|
28 |
|
|
Restructuring costs and similar
items |
1,062 |
|
1,480 |
|
|
Other gains and losses, and
litigation(3) |
(327) |
|
(502) |
|
|
Effects of IFRS 16 on Lease
contracts(4) |
37 |
|
— |
|
|
Tax effect of the items listed above
: |
(1,866) |
|
(1,125) |
|
|
Amortization and impairment of intangible assets |
(1,409) |
|
(692) |
|
|
Fair value remeasurement of contingent consideration |
(6) |
|
38 |
|
|
Expenses arising from the impact of acquisitions on
inventories |
— |
|
(27) |
|
|
Other expenses related to business combinations |
— |
|
(6) |
|
|
Restructuring costs and similar items |
(309) |
|
(435) |
|
|
Other tax effects |
(142) |
|
(3) |
|
|
Other tax items(5) |
— |
|
(188) |
|
|
Share of items listed above
attributable to non-controlling interests |
(4) |
|
(2) |
|
|
Restructuring costs of associates and
joint ventures, and expenses arising from the impact of
acquisitions on associates and joint ventures |
165 |
|
(76) |
|
|
Animal Health items |
101 |
|
13 |
|
|
Business net
income |
7,489 |
|
6,819 |
|
9.8% |
IFRS earnings per share (6) (in
euros) |
2.24 |
|
3.45 |
|
|
- Of which related to amortization expense generated by
the remeasurement of intangible assets as part of business
combinations: €2 044 million in 2019 and €1,957 million in
2018.
- In 2019, of which Eloctate impairment (€2,803 million)
and Zantac impairment (€352 million) and internal or collaboration
development projects impairment (€280 million)
- In 2019, mainly related to litigation settlement. In
2018, separation costs for the European Generics business
divestiture.
- Impact of new lease standard IFRS 16, is effective
January 1, 2019 using the modified retrospective transition method
(no restatement of prior periods), since Business Net Income
remains reported as previously under IAS 17 and related
interpretations for comparison purposes.
- In 2018, mainly due to US tax reform
- Based on an average number of shares outstanding of
1,249.9 million in 2019 and 1,247.1 million in 2018.
Appendix 5: Change in net
debt
€ million |
2019 |
2018 |
|
|
|
Business net
income |
7,489 |
6,819 |
Depreciation & Amortization &
impairment of property, plant and equipment and software |
1,316 |
1,208 |
Other non-cash items |
434 |
(193) |
Operating cash flow before
changes in working capital |
9,239 |
7,834 |
Changes in Working Capital |
(580) |
(1,099) |
Acquisitions of property, plant and
equipment and software |
(1,405) |
(1,674) |
Free cash flow before
restructuring, acquisitions and disposals |
7,254 |
5,061 |
Acquisitions of intangibles assets,
investments and other long term financial assets(1) |
(576) |
(635) |
Restructuring costs and similar items
paid |
(1,142) |
(894) |
Proceeds from disposals of property,
plant and equipment, intangible assets and other non-current assets
net of tax (1) |
490 |
522 |
Free cash-flow |
6,026 |
4,054 |
Acquisitions of investments in
consolidated undertakings including assumed debt(2) |
— |
(12,728) |
Proceeds from disposals of assets net
of tax(2) |
672 |
1,592 |
Net cash flow from the swap between
BI-CHC and Sanofi Animal Health business |
105 |
— |
Issuance of Sanofi shares |
162 |
177 |
Acquisition of treasury shares |
(9) |
(1,104) |
Dividends paid to shareholders of
Sanofi |
(3,834) |
(3,773) |
Other items |
(601) |
(685) |
Change in net
debt |
2,521 |
(12,467) |
|
|
|
Beginning of
period |
17,628 |
5,161 |
Closing of net
debt |
15,107 |
17,628 |
(1) Free cash flow
includes investments and divestments not exceeding a cap of €500
million per transaction. (2) Includes transactions that are above a
cap of € 500 million per transaction. |
Appendix 6: Simplified consolidated balance
sheet
ASSETS€
million |
Dec 31,2019 |
Dec 31,2018 |
|
LIABILITIES &
EQUITY€ million |
Dec 31,2019 |
Dec 31,2018 |
|
|
|
|
Equity attributable to equity holders
of Sanofi |
58,934 |
58,876 |
|
|
|
|
Equity attributable to non-controlling
interests |
174 |
159 |
|
|
|
|
Total equity |
59,108 |
59,035 |
|
|
|
|
Long-term debt |
20,131 |
22,007 |
Property, plant and equipment - Owned
assets |
9,717 |
9,651 |
|
Long-term lease liability |
987 |
— |
Right of use |
1,300 |
— |
|
Non-current liabilities related to
business combinations and to non-controlling interests |
508 |
963 |
Intangible assets (including
goodwill) |
61,091 |
66,124 |
|
Provisions and other non-current
liabilities |
9,321 |
8,613 |
Non-current financial assets &
investments in associates and deferred tax assets |
11,692 |
10,986 |
|
Deferred tax liabilities |
2,294 |
3,414 |
Non-current assets |
83,300 |
86,761 |
|
Non-current
liabilities |
33,241 |
34,997 |
|
|
|
|
Accounts payable & Other current
liabilities |
15,274 |
14,402 |
|
|
|
|
Current liabilities related to business
combinations and to non-controlling interests |
292 |
341 |
Inventories, accounts receivable and other
current assets |
19,184 |
17,654 |
|
Short-term lease liability |
261 |
— |
Cash and cash equivalents |
9,427 |
6,925 |
|
Short-term debt and current portion of
long-term debt |
4,554 |
2,633 |
Current assets |
28,611 |
24,579 |
|
Current
liabilities |
20,381 |
17,376 |
Assets held for sale or exchange |
325 |
68 |
|
Liabilities related to assets held for
sale or exchange |
6 |
— |
Total ASSETS |
112,736 |
111,408 |
|
Total LIABILITIES &
EQUITY |
112,736 |
111,408 |
Appendix 7: Other current operating income net
of expenses – Regeneron Alliances
€ million |
2019 |
2018 |
Antibodies Alliance |
|
|
Income & Expense related to profit/loss sharing |
(253) |
177 |
Additional share of profit paid by Regeneron related to development
costs |
21 |
- |
Regeneron commercial operating expenses reimbursement |
(449) |
(388) |
Total Antibodies Alliance |
(681) |
(211) |
Immuno-Oncology
Alliance |
|
|
Total Immuno-Oncology Alliance |
62 |
4 |
Other Regeneron |
|
|
Total others related to Regeneron (mainly Zaltrap) |
(14) |
(14) |
Total Regeneron
Alliances |
(633) |
(221) |
Appendix 8: Currency
sensitivity
2020 business EPS currency
sensitivity
Currency |
Variation |
Business EPS Sensitivity |
U.S. Dollar |
+0.05
USD/EUR |
-EUR
0.13 |
Japanese Yen |
+5
JPY/EUR |
-EUR
0.02 |
Chinese Yuan |
+0.2
CNY/EUR |
-EUR
0.02 |
Brazilian Real |
+0.4
BRL/EUR |
-EUR
0.01 |
Russian
Ruble |
+10 RUB/EUR |
-EUR 0.03 |
Currency exposure on Q4 2019
sales
Currency |
Q4 2019 |
US
$ |
39.3% |
Euro
€ |
22.2% |
Chinese Yuan |
4.7% |
Japanese Yen |
4.7% |
Brazilian Real |
2.3% |
Mexican Peso |
2.2% |
British Pound |
1.8% |
Russian Ruble |
1.7% |
Canadian $ |
1.6% |
Turkish Lira |
1.4% |
Others |
18.1% |
Currency average rates
|
Q4 2018 |
Q4 2019 |
Change |
€/$ |
1.14 |
1.11 |
-3.0% |
€/Yen |
128.82 |
120.37 |
-6.6% |
€/Yuan |
7.90 |
7.80 |
-1.2% |
€/Real |
4.35 |
4.56 |
+5.0% |
€/Ruble |
75.91 |
70.56 |
-7.0% |
Appendix 9: R&D
Pipeline
New Molecular
Entities(*)
Phase 1 (Total : 21) |
Phase 2 (Total : 7) |
Phase 3 (Total : 8) |
Registration (Total : 2) |
SAR441344(**)(1)Anti-CD40L
mAbMultiple Sclerosis |
ST400(**)(5) Ex
Vivo ZFN Gene-Edited Cell Therapy, Beta thalassemia |
SAR440340(**)(11)Anti-IL33 mAbAtopic
Dermatitis |
SAR422459(**)(13) ABCA4 gene therapy Stargardt
Disease |
avalglucosidase alfaNeo GAA Pompe Disease |
Sarclisa® Anti-CD38 mAb3L RRMM (ICARIA)
(U.S.,EU) |
SAR439459 anti-TGFb mAbAdvanced Solid Tumors |
BIVV003(**)(5)
Ex Vivo ZFN Gene-Edited Cell Therapy, Sickle Cell Disease |
romilkimab
(SAR156597) Anti-IL4/IL13 bispecific mAb Systemic
Scleroderma |
SAR442168(**)(14)BTK
inhibitor Multiple Sclerosis |
venglustatOral GCS inhibitorADPKD(15) |
SAR341402 (insulin aspart) Rapid
acting insulin Type 1/2 Diabetes (EU) |
O |
REGN5458(**)(2)Anti-BCMAxCD3 bispecific
mAbRelapsed Refractory MM |
BIVV020 Complement C1s inhibitor |
R |
olipudase
alfa rhASM ASMD(12) ad+ped |
R |
SAR439859 SERDMetastatic Breast Cancer 2/3L |
fitusiran RNAi targeting anti-thrombin Hemophilia
A and B |
|
|
|
|
O |
REGN4018(**)(2)Anti-MUC16xCD3
bispecific mAbOvarian Cancer |
SAR443060(**)(6) RIPK1
inhibitor(7)Amyotrophic Lateral Sclerosis |
SAR339375miRNA-21Alport Syndrome |
|
sutimlimabAnti Complement C1s mAb Cold Agglutinin
Disease |
|
|
SAR442720(**)(3) SHP2 inhibitorSolid Tumors |
SAR443122(**)(6) RIPK1
inhibitor(7) Inflammatory indications |
|
|
BIVV001(**)(16)
rFVIIIFc – vWF – XTEN(17) Hemophilia A |
|
SAR440234 T cell engaging multi specific mAb,
Leukemia |
SAR441169(**)(8)
RORC (ROR gamma T) antagonist, Psoriasis |
|
|
nirsevimab(**)(18) Respiratory
syncytial virusMonoclonal Antibody |
|
SAR441000(**)(4)
Cytokine mRNASolid tumors |
SAR441236 Tri-specific neutralizing
mAbHIV |
|
|
SAR408701 Maytansin-loaded anti-CEACAM5 mAb, NSCLC
2/3L |
|
SAR442085 Anti CD38 mAb Fc engineered
Multiple Myeloma |
Next Gen
PCV(**)(9) Pneumococcal
Conjugate Vaccines |
|
|
efpeglenatide(19) Long-acting
GLP-1 agonist Type 2 Diabetes |
|
O |
REGN5459(**)(2)Anti-BCMAxCD3 bispecific
mAbRelapsed Refractory MM |
Herpes Simplex Virus Type
2(**)(10) HSV-2 therapeutic vaccine |
|
|
|
|
|
THOR-707Non-alpha IL-2Solid tumors |
Respiratory syncytial virus Infants 4-month and
older Vaccines |
|
|
|
|
|
Yellow Fever Vaccine (Vero cells) |
|
|
|
|
|
Immuno-inflammation |
|
Rare Blood Disorders |
|
Cardiovascular &
metabolism |
|
Oncology |
|
MS & Neuro |
|
Vaccines |
|
Rare Diseases |
|
Diabetes |
|
|
- Developed in collaboration with Immunext
- Regeneron product for which Sanofi has opt-in
rights
- Developed in collaboration with Revolution
Medicines
- Developed in collaboration with BioNTech
- Developed in collaboration with Sangamo
- Developed in collaboration with Denali
- Receptor-interacting serine/threonine-protein kinase
1
- Developed in collaboration with Lead
Pharma
- Developed in collaboration with SK
- Developed in collaboration with Immune
Design/Merck
- Developed in collaboration with Regeneron
- Acid Sphingomyelinase Deficiency also known as Niemann
Pick type B
- Identification of out-licensing partner
ongoing
- Developed in collaboration with Principia
- Autosomal Dominant Polycystic Kidney
Disease
- Developed in collaboration with Sobi
- Recombinant Coagulation Factor VIII Fc – von Willebrand
Factor – XTEN Fusion protein
- Developed in collaboration with
AstraZeneca
- Developed in collaboration with Hamni – Sanofi has
committed to complete ongoing studies – Sanofi is looking for a
partner to take over and commercialize efpeglenatide
O : Opt-in rights products for which rights have
not been exercised yetR : Registrational
Study (other than Phase 3) (*) Phase of
projects determined by clinicaltrials.gov disclosure timing when
relevant(**) Partnered and/or in collaboration –
Sanofi may have limited or shared rights on some of these
productsmAb = monoclonal antibody; RRMM = Relapsed
Refractory Multiple Myeloma; GCS = glucosylceramide
synthase
Additional
Indications(*)
Phase 1 (Total : 7) |
Phase 2 (Total : 17) |
Phase 3 (Total : 26) |
Registration (Total : 3) |
SAR439459 +
cemiplimab(**)(1) Advanced Solid Tumors |
dupilumab(**)(1) Grass pollen allergy |
Isatuximab + cemiplimab(**)(1) Relapsed Refractory
MM |
Dupixent® (**)(1) Asthma 6 - 11 years old |
isatuximabNewly Diag. MM Te(9) (GMMG) |
Fluzone® QIV HD Influenza - High dose (EU) |
O |
cemiplimab(**)(1) + REGN4018(2)(**)Ovarian
Cancer |
R |
sarilumab(**)(1) Polyarticular JIA(7) |
isatuximab +
cemiplimab(**)(1) Lymphoma |
dupilumab(**)(1) Eosinophilic Esophagitis |
isatuximab2L RRMM (IKEMA) |
MenQuadfi TM U.S. 2y+ , EU
1y+ |
|
|
SAR439859 +
palbociclib(3)Metastatic Breast
Cancer |
R |
sarilumab(**)(1) Systemic Juvenile Arthritis |
isatuximab +
atezolizumab(8) mCRC |
Dupixent®(**)(1) AD 6 months - 5
years old |
isatuximab 1L Newly Diag. MM Ti(10) (IMROZ) |
Dupixent®(**)(1) AD 6 – 11 years old (U.S.,
EU) |
|
sutimlimab ImmuneThrombocytopenic Purpura |
SAR440340(**)(1) COPD |
isatuximab + atezolizumab(8) Solid Tumors |
dupilumab(**)(1) COPD |
Aubagio® Relapsing MS –
Pediatric |
|
SAR443060(4)Multiple sclerosis |
dupilumab(**)(1) Peanut Allergy - Pediatric |
venglustatFabry Disease |
dupilumab(**)(1) Bullous pemphigoid |
Lemtrada® RRMS - Pediatric |
|
SAR442720(**)(5) +
cobimetinib Relapsed Refractory solid
tumors |
SAR440340(**)(1) Asthma |
venglustatGaucher Type 3 |
dupilumab(**)(1) Chronic spontaneous
urticaria |
Cerdelga®Gaucher T1, ERT switch
Pediatric |
|
SAR441000(**)(6)
+ PD-1 Solid tumors |
R |
cemiplimab(**)(1)2L Basal Cell Carcinoma |
venglustatParkinson’s Disease with an associated
GBA mutation |
dupilumab(**)(1) Prurigo nodularis |
Praluent®
(**)(1)LDL-C reduction - Pediatric |
|
|
|
isatuximab1-2L AML / ALL pediatrics |
SP0173 Tdap booster US |
sarilumab(**)(1) Giant Cell
Arteritis |
Praluent®
(**)(1)LDL-C reduction - HoFH |
|
|
SAR439859 Breast Cancer adjuvant |
|
sarilumab(**)(1) Polymyalgia
Rheumatica |
MenQuadfi TM US / EU 6w+ |
|
|
|
|
cemiplimab(**)(1)1L NSCLC |
Pediatric pentavalent vaccine(**)(11) Japan |
|
|
|
|
cemiplimab(**)(1) + chemotherapy1L NSCLC |
Shan 6 Pediatric hexavalent vaccine |
|
|
|
|
cemiplimab(**)(1)2L Cervical Cancer |
VerorabVax® (VRVg) Purified vero rabies
vaccine |
|
|
|
|
cemiplimab(**)(1)Adjuvant in CSCC |
fitusiran Hemophilia A and B pediatric |
|
- Developed in collaboration with Regeneron
- Regeneron product for which Sanofi has opt-in
rights
- Pfizer product (palbociclib)
- Developed in collaboration with Denali
- Developed in collaboration with Revolution Medicines -
cobimetinib is a Genentech product
- Developed in collaboration with BioNTech
- Polyarticular JIA = Polyarticular Juvenile Idiopathic
Arthritis
- Studies in collaboration with Genentech Inc.
(atezolizumab)
- Transplant eligible
- Transplant ineligible
- Developed in collaboration with Kitasato and Daiichi
Sankyo (KDSV)
(*) Phase of projects
determined by clinicaltrials.gov disclosure timing when
relevant(**) Partnered and/or in
collaboration - Sanofi may have limited or shared rights on some of
these products O :
Opt-in rights products for which rights have not been
exercised yet R :
Registrational Study (other than Phase
3)COPD = chronic obstructive pulmonary disease;
AML = acute myeloïd leukemia; ALL = acute lymphoblastic leukemia;
MM = multiple myloma;RRMS = Relapsing / Remitting Multiple
Sclerosis
Expected Submission
Timeline(1)
NMEs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SAR442168(**)(8)
Multiple Sclerosis |
|
|
|
SAR439859 mBC 2/3L |
|
BIVV001(**)(6)Hemophilia A |
|
romilkimab Systemic scleroderma |
SAR339375Alport Syndrome |
sutimlimabCold Agglutinin Disease |
avalglucosidase alfa Pompe Disease |
fitusiran Hemophilia A/B |
olipudase alfa ASMD(4) ad+ped |
venglustatADPKD(7) |
SAR408701 2-3LNSCLC |
SAR440340(**)(3)Atopic Dermatitis |
nirsevimab (9)(**) Respiratory Syncytial
Virus |
|
2020(2) |
2021(2) |
2022(2) |
2023(2) and beyond |
ADDITIONAL INDICATIONS |
isatuximab 2L RRMM (IKEMA) |
Aubagio® Relapsing MS – Ped |
Dupixent® (**)(3) Asthma 6 - 11 y old |
isatuximab1L Newly Diag MM Ti(5) |
Dupixent®(**)(3) AD 6 m - 5 y
old |
Cerdelga®Gaucher T1, ERT switch,
Ped |
SAR440340(**)(3) COPD |
isatuximabNewly Diag MM Te(10) |
cemiplimab(**)(3) 2L BCC |
Shan 6 Ped hexavalent vaccine |
sarilumab(**)(3) Polyarticular JIA |
cemiplimab(**)(3) 2L Cervical Cancer |
dupilumab(**)(3)Eosinophil. esophagitis |
sarilumab(**)(3) Polym.Rheumatica |
SAR440340(**)(3)Asthma |
venglustatGBA-PD(11) |
Praluent®(**)(3)LDL-C
reduction, HoFH |
|
dupilumab(**)(3)Prurigo nodularis |
cemiplimab(**)(3)(12)1L NSCLC |
dupilumab(**)(3)Chronic spontaneous urticaria |
sarilumab(**)(3) Giant Cell
Arteritis |
Ped. pentavalent vaccine(**)(13)
(Japan) |
venglustatFabry Disease |
|
|
|
|
dupilumab(**)(3)Bullous pemphigoid |
Praluent®(**)(3)LDL-C
reduction – Ped |
MenQuadfiTM U.S.& EU 6w+ |
VerorabVax® (VRVg) Purified vero rabies
vaccine |
|
|
|
|
|
|
Lemtrada® RRMS ped |
SP0173 Tdap booster US |
|
|
|
|
|
|
isatuximab1-2L AML / ALL ped |
dupilumab(**)(3)COPD |
|
|
|
|
|
|
|
cemiplimab(**)(3) + chemo 1L NSCLC |
cemiplimab(**)(3) adjuvant in CSCC |
|
|
|
|
|
|
|
venglustatGaucher Type 3 |
sarilumab(**)(3) Systemic Juv. Arthritis |
- Excluding Phase 1 without POC
- Projects within a specified year are not arranged by
submission timing
- Developed in collaboration with Regeneron
- Acid Sphingomyelinase Deficiency
- Transplant ineligible
- Developed in collaboration with Sobi
- Autosomal Dominant Polycystic Kidney
Disease
- Developed in collaboration with Principia
- Developed in collaboration with
AstraZeneca
- Transplant eligible
- Parkinson’s Disease with an associated GBA
mutation
- cemiplimab 1L NSCLC submission is expected in
2020-2021
- Developed in collaboration with Kitasato and Daiichi
Sankyo (KDSV)
(**) Partnered and/or in collaboration
– Sanofi may have limited or shared rights on some of these
products
Pipeline Movements
Since Q3 2019
|
Additions & Moves |
Removals from Sanofi pipeline |
Registration |
Dupixent®(**)(1)) AD 6 – 11 years old (U.S.,
EU) |
|
|
|
Phase 3 |
BIVV001(**)(2)
rFVIIIFc – vWF – XTEN(3) Hemophilia A |
|
|
|
SAR408701 Maytansin-loaded anti-CEACAM5 mAb NSCLC
2/3L |
dupilumab(**)1)Chronic spontaneous urticaria |
|
|
dupilumab(**)(1) Bullous pemphigoid |
dupilumab(**)(1) Prurigo nodularis |
|
|
Phase 2 |
SAR439859 SERDMetastatic Breast Cancer 2/3L |
SAR439859 Breast Cancer adjuvant |
HIV Viral vector prime & rgp120 boost
vaccine |
|
Phase 1 |
SAR441000(**)(4)
+ PD-1 Solid tumors |
Yellow Fever Vaccine (Vero cells) |
|
|
THOR-707Non-alpha IL-2Solid tumors |
|
|
|
- Developed in collaboration with Regeneron
- Developed in collaboration with Sobi
- Recombinant Coagulation Factor VIII Fc – von Willebrand
Factor – XTEN Fusion protein
- Developed in collaboration with BioNTech
- Developed in collaboration with Hamni – Sanofi has
committed to complete ongoing studies – Sanofi is looking for a
partner to take over and commercialize efpeglenatide
(**) Partnered and/or in
collaboration – Sanofi may have limited or shared rights on some of
these products
Appendix 10: Expected R&D
milestones
Products |
Expected milestones |
Timing |
cemiplimab(1)(**) |
Pivotal trial read-out in 2L Basal Cell Carcinoma |
H1 2020 |
Sarclisa® |
U.S. and EU regulatory decisions in 3L Relapsed-Refractory Multiple
Myeloma |
Q2 2020 |
Dupixent®(1)(**) |
U.S. regulatory decision in Atopic Dermatitis for 6-11 year-old age
group(2) |
Q2 2020 |
MenQuadfiTM |
U.S. regulatory decision for ≥ 2-year old age group |
Q2 2020 |
Fluzone® QIV HD |
EU regulatory decision for ≥ 65-year old age group |
Q2 2020 |
avalglucosidase alfa |
Pivotal trial read-out in Late Onset Pompe Disease |
Q2 2020 |
isatuximab |
Pivotal trial read-out in 2L Relapsed-Refractory Multiple Myeloma
(IKEMA) |
Q2 2020 |
Dupixent®(1)(**) |
Part A readout from pivotal trial in Eosinophilic Esophagitis |
Q2-Q3 2020 |
sutimlimab |
U.S. regulatory decision in Cold Agglutinin Disease |
Q3 2020 |
SAR440340(1)(**) (anti-IL33 mAb) |
Proof of concept study read-out in Atopic Dermatitis |
Q3 2020 |
SAR439859 (SERD) |
Proof of concept study read-out in Breast Cancer (combo, adj.) |
H2 2020 |
Flublok® |
EU regulatory decision for > 50-year old age group |
Q4 2020 |
MenQuadfi™ |
EU regulatory decision for ≥ 12-month old age group |
Q4 2020 |
Dupixent®(1)(**) |
Pivotal trial read-out in Asthma for 6-11 year old age group |
Q4 2020 |
- Developed in collaboration with Regeneron
- Granted breakthrough designation and priority review
with FDA Decision May 26, 2020
(**) Partnered and/or in collaboration – Sanofi
may have limited or shared rights on some of these
products
QIV: Quadrivalent Influenza Vaccine; HD: High-Dose
Appendix 11: Definitions of non-GAAP financial
indicators
Company
“Company” corresponds to Sanofi and its
subsidiaries.
Company sales at constant exchange rates
(CER)
When we refer to changes in our net
sales “at constant exchange rates” (CER), this means that we
exclude the effect of changes in exchange rates.
We eliminate the effect of exchange
rates by recalculating net sales for the relevant period at the
exchange rates used for the previous period.
Reconciliation of net sales to Company sales at
constant exchange rates for the fourth quarter and full-year
2019
€ million |
Q4 2019 |
2019 |
Net sales |
9,608 |
36,126 |
Effect of exchange rates |
184 |
688 |
Company sales at constant exchange rates |
9,424 |
35,438 |
Business net income
Sanofi publishes a key non-GAAP
indicator. Business net income is defined as net
income attributable to equity holders of Sanofi
excluding:
- amortization of intangible
assets,
- impairment of intangible
assets,
- fair value remeasurement of
contingent consideration related to business combinations or to
disposals,
- other impacts associated
with acquisitions (including impacts of acquisitions on associates
and joint ventures),
- restructuring costs and
similar items(1),
- other gains and losses
(including gains and losses on disposals of non-current
assets(1)),
- effects of IFRS16 on lease
accounting,
- costs or provisions
associated with litigation(1),
- tax effects related to the
items listed above as well as effects of major tax
disputes,
- net income attributable to
non-controlling interests related to the items listed
above,
(1) Reported in the line
items Restructuring costs and similar
items and Gains and losses on disposals, and
litigation, which are defined in Notes B.19. and B.20. to
our consolidated financial statements.
Free Cash Flow
Free Cash Flow is a non-GAAP financial
indicator which is reviewed by our management, and which we believe
provides useful information to measure the net cash generated from
the Company’s operations that is available for strategic
investments1 (net of divestments1), for debt repayment, and
for capital return to shareholders. Free Cash Flow is determined
from the Business Net Income adjusted for depreciation,
amortization and impairment, share of profit/loss in associates and
joint ventures net of dividends received, gains & losses on
disposals, net change in provisions including pensions and other
post-employment benefits, deferred taxes, share-based expense and
other non-cash items. It comprises net changes in working capital,
capital expenditures and other asset acquisitions2 net of
disposal proceeds2, and payments related to restructuring and
similar items. Free Cash Flow is not defined by IFRS and it
is not a substitute measure for the IFRS aggregate net cash flows
in operating activities.1Amount of the transaction
above a cap of €500 million per transaction.2Not
exceeding a cap of €500 million per transaction.
IFRS 16
The new lease accounting standard
(IFRS16) impact mainly comes from the amortization of the lease
asset recognized on a straight-line basis while the interest
expense decreases over the life of the lease. IFRS16 standard is
effective as of 1 January 2019. The impact on business EPS is -2
cents in 2019. In 2020, Sanofi will report Business Net Income and
2019 comparative, applying IFRS16 for both periods. 2019
comparative numbers will be available in Q1 2020.
Attachment
Sanofi (BIT:1SAN)
Gráfico Histórico do Ativo
De Fev 2024 até Mar 2024
Sanofi (BIT:1SAN)
Gráfico Histórico do Ativo
De Mar 2023 até Mar 2024